Prosthesis, Intervertebral Disc
Unknown
Recent MDR events
6,148 adverse event reports on file
- Simplify® Cervical Artificial DiscJul 31, 2026InjuryNuvasive, Inc.2031966-2026-00096
- Simplify® Cervical Artificial DiscJul 31, 2026InjuryNuvasive, Inc.2031966-2026-00097
- PRODISC C VIVO US IMPLANT LARGE 5mmJul 29, 2026InjuryCentinel Spine, Llc3007494564-2026-00068
- BRYAN® CERVICAL DISC SYSTEMJul 22, 2026InjuryWarsaw Orthopedic, Inc.1824199-2026-00076
- MOBI-C IMPLANT "M" STANDARD 15X17 H5 USJul 21, 2026MalfunctionLdr Medical3004788213-2026-00051
- SIMPLIFY® CERVICAL ARTIFICIAL DISCJul 21, 2026MalfunctionNuvasive, Inc.2031966-2026-00090
- SIMPLIFYJul 16, 2026MalfunctionNuvasive, Inc.2031966-2026-00089
- PRODISC L INFERIOR END PLATEJul 15, 2026InjuryCentinel Spine, Llc3007494564-2026-00067
- PRODISC L SUPERIOR END PLATEJul 15, 2026InjuryCentinel Spine, Llc3007494564-2026-00065
- PRODISC L PE-INLAY W/ X-RAY MARKERJul 15, 2026InjuryCentinel Spine, Llc3007494564-2026-00066
Event type breakdown
Recalls
15 recall events for this product code
- Centinel Spine, Inc.Open, ClassifiedMay 1, 2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Z-2050-2026 · View FDA record ↗ - Centinel Spine, Inc.Open, ClassifiedMay 1, 2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6.
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Z-2051-2026 · View FDA record ↗ - Centinel Spine, Inc.Open, ClassifiedFeb 17, 2026
Brand Name: Prodisc
Products were mislabeled as the 6mm product but included the 5 mm product.
Z-1426-2026 · View FDA record ↗ - Centinel Spine, Inc.Open, ClassifiedSep 24, 2024
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Z-3212-2024 · View FDA record ↗ - Centinel Spine, Inc.Open, ClassifiedSep 24, 2024
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Z-3213-2024 · View FDA record ↗ - Medicrea InternationalOpen, ClassifiedAug 24, 2023
GRANVIA-C, REF numbers:
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Z-2459-2023 · View FDA record ↗ - Medtronic Sofamor Danek USA IncTerminatedDec 19, 2007
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactur
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Z-0138-2008 · View FDA record ↗ - Medtronic Sofamor Danek USA IncTerminatedDec 19, 2007
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, SIZE 6 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactu
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Z-0139-2008 · View FDA record ↗ - Medtronic Sofamor Danek USA IncTerminatedDec 19, 2007
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972266, SIZE 6 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactur
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Z-0140-2008 · View FDA record ↗ - Medtronic Sofamor Danek USA IncTerminatedDec 19, 2007
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactu
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Z-0141-2008 · View FDA record ↗
Registered firms
117 firms currently registered for this product code
Sterigenics Us, Llc
Lewis Center, OH, US
Viant Chaumont S.a.s.
CHAUMONT Haute-Marne, FR
Isomedix Operations Inc.
CHESTER, NY, US
Paragon Medical - Dayton
Dayton, OH, US
Fruh Packaging Inc.
Exton, PA, US
K2m, Inc.
Leesburg, VA, US
Warsaw Orthopedic, Inc.
WARSAW, IN, US
Nml Medical, Llc
West Carrollton, OH, US
Olive Branch Distribution Center
Olive Branch, MS, US
Synthes (usa) Products Llc
West Chester, PA, US
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Nuvasive, Inc.
SAN DIEGO, CA, US
Bricon Technology Gmbh
WURMLINGEN Baden-Wurttemberg, DE
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Sterigenics Us Llc
Gurnee, IL, US
Jabil Inc. (brandywine)
W Chester, PA, US
Steris Schweiz Ag
Daniken Solothurn, CH
Riverside Machine & Engineering, Inc.
Eau Claire, WI, US
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Centinel Spine, Llc
West Chester, PA, US
Orchid Orthopedic Solutions Alabama Llc
Arab, AL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
14 premarket approvals for this product code
- Synergy Spine Solutions, Inc.Feb 26, 2026
P250028 · Synergy Disc
- Nuvasive, Inc.Sep 18, 2020
P200022 · Simplify® Cervical Artificial Disc
- Spinal Kinetics, LLCFeb 6, 2019
P170036 · M6-C Artificial Cervical Disc
- Highridge Medical, LLCJun 11, 2015
P120024 · ACTIVL ARTIFICIAL DISC
- Medtronic Sofamor Danek USA, Inc.Jul 24, 2014
P090029 · PRESTIGE LP CERVICAL DISC
- Highridge Medical, LLCAug 23, 2013
P110009 · MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
- Highridge Medical, LLCAug 7, 2013
P110002 · MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
- Nuvasive, Inc.Oct 26, 2012
P100012 · NUVASIVE PCM CERVICAL DISC SYSTEM