COMBINED SUBMALAR SHELL
Received Jul 16, 2026 · Event occurred Jul 6, 2026
Report 2028924-2026-00004 · MDR key 25845808
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
62 YR · Male
- Implant Pain
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
INVESTIGATION: COMPLAINANT REPORTED PATIENT WITH PAIN AND SWELLING AT THE SURGICAL SITE, AND DEVICE WAS SUBSEQUENTLY FOUND TO BE EXPOSED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ERRORS OR OMISSIONS THAT MIGHT ACCOUNT FOR THE REPORTED EVENT. LABELING INCLUDES CITATIONS THAT "INADEQUATE TISSUE COVERING, INADEQUATE SIZE SURGICAL POCKET OR TOO LARGE AN IMPLANT CAN RESULT IN NECROSIS AND EXTRUSION OF THE IMPLANT". REVIEW OF COMPLAINT HISTORY DOES NOT SUGGEST THAT EVENTS OF THIS KIND ARE OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN ANTICIPATED. POSSIBLE CONTRIBUTING FACTORS FOR THIS EVENT (EXPOSURE/EXTRUSION) MAY INCLUDE SUCH THINGS AS INADEQUATE SOFT TISSUE COVERAGE, IMPLANT SIZING/POCKET MISMATCH, WOUND HEALING COMPLICATIONS, EARLY INFECTION, NON-COMPLIANCE WITH POST-OP CARE, ETC., HOWEVER IMPLANTECH IS UNABLE TO IDENTIFY ANY ASSIGNABLE CAUSE FOR THE REPORTED EVENT. THE SURGEON PLANS TO REPLACE IT WITH A SMALLER-SIZED IMPLANT.
Description of Event or Problem
ONE WEEK POST-IMPLANT SURGERY, THE PATIENT B.B. RETURNED FOR A ROUTINE FOLLOW-UP VISIT PRESENTING WITH PAIN AND SWELLING AT THE SURGICAL SITE. UPON EXAMINATION, THE COMBINED SUBMALAR SHELL IMPLANT WAS FOUND TO BE EXPOSED. THE SUBSTITUTE PHYSICIAN EXPLANTED THE DEVICE ON (B)(6) 2026. NO ADDITIONAL COMPLICATIONS, ADVERSE EVENTS, OR INTERVENTIONS WERE REPORTED AT THE TIME OF EXPLANT. THE PATIENT IS STABLE AND PLANS TO UNDERGO A FUTURE SURGERY TO REPLACE THE DEVICE.