1.5MM T/Y LOCKING PLATE ST
Received Nov 12, 2021
Report 0001822565-2021-03279 · MDR key 12804355
Device
Product problems
- Fracture
- Migration
- Fracture
- Migration
Patient
Unknown
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4). UPDATED: B4, B5, D1, D4 (ITEM #), G3, H1, H2, H10. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative
(B)(4). UPDATED: B4, B5, G3, H1, H2, H10. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A SUBSIDED AND FRACTURED PLATE AND THREE FRACTURED SCREWS. THE COMPONENTS WERE USED FOR SPHENOID OSTEOTOMY OF THE FOOT BONE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Description of Event or Problem
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).
Additional Manufacturer Narrative
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: UNKNOWN, SCREW, LOT # UNKNOWN CATALOG #: UNKNOWN, SCREW, LOT # UNKNOWN CATALOG #: UNKNOWN, SCREW, LOT # UNKNOWN REPORT SOURCE :(B)(6). DEVICE EVALUATED BY MFR: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. REPORTED EVENT WAS CONFIRMED AS THE RADIOGRAPHS SHOWED THAT THE PLATE IS FRACTURED AS WELL AS AT LEAST THREE OF THE FIXATION SCREWS. THE METATARSAL OSTEOTOMY IS DISPLACED. THE FRACTURED SCREWS APPEAR LOOSE. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. REMAINS IMPLANTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT'S IMPLANT SUBSIDED . THE COMPONENTS WERE USED FOR SPHENOID OSTEOTOMY OF THE FOOT BONE. IT WAS FURTHER REPORTED THAT A PATIENT'S IMPLANT SUBSIDED AS WELL AS THE PLATE AND 3 SCREWS FRACTURED. THE COMPONENTS WERE USED FOR SPHENOID OSTEOTOMY OF THE FOOT BONE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Additional Manufacturer Narrative
(B)(4). UPDATED: B4, B5, D1, D2, D4 (ITEM #), G3, H1, H2, H10 IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.