FDA Adverse Event Malfunction Summary report: N

FINE OSTEOTOMY

MDR report key: 17950052 · Received October 17, 2023

Report

Report Number
3012086398-2023-00001
Event Type
Malfunction
Date Received
October 17, 2023
Date of Event
December 2, 2022
Report Date
October 16, 2023
Manufacturer
BODYCAD LABORATORIES INC,
Product Code
HRS
UDI-DI
00688346002140
PMA / PMN Number
K231314
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

THE PATIENT UNDERWENT A LATERAL OPENING WEDGE DISTAL FEMUR OSTEOTOMY (DFO) TO ADDRESS A VALGUS DEFORMITY AROUND THE KNEE. ADDITIONALLY, THE PATIENT RECEIVED A LATERAL FEMORAL CONDYLE OSTEOCHONDRAL ALLOGRAFT. THE DFO PROCEDURE WAS PERFORMED IN THE STANDARD MANNER, AND ALTHOUGH THE MEDIAL HINGE CRACKED, IT WAS NOT STABILIZED. THE DFO OSTEOTOMY WAS SECURED WITH A BODYCAD PERSONALIZED PLATE, AND THE GAP WAS FILLED WITH A BONE GRAFT. THE INITIAL POST-OPERATIVE X-RAY SHOWED THAT THE PLATE WAS WELL-POSITIONED, AND THE SCREWS WERE OF THE APPROPRIATE LENGTH AS PLANNED.THE PATIENT RETURNED FOR A ROUTINE CHECKUP SIX WEEKS POST-OP, WHERE IT WAS NOTED THAT ONE OF THE DISTAL SCREWS (D) HAD SLIGHTLY BACKED OUT, AND ANOTHER SCREW (B) WAS SLIGHTLY BENT. HOWEVER, THE PLATE REMAINED STABLE, AND THE MICRO-FRACTURE AT THE HINGE SITE WAS SHOWING GOOD CONSOLIDATION. THERE WAS EXCELLENT BONE HEALING AND PROPER CONSOLIDATION OF THE OSTEOTOMY, WITH NO LOSS OF CORRECTION.AT THE SECOND ROUTINE CHECKUP, 12 WEEKS POST-OP, NO SIGNS OF INFECTION WERE OBSERVED. TWO SCREWS (C AND D) HAD BACKED OUT SLIGHTLY BUT REMAINED STABLE AND HAD NOT MOVED BEYOND THE LOCKING MECHANISM (3 MM). ALL OTHER SCREWS' THREADS WERE WITHIN THE BONE STRUCTURE, AND THERE WAS CONTINUED EXCELLENT HEALING AT THE OSTEOTOMY SITE. UNFORTUNATELY, SCREW B HAD FAILED, BUT THIS WAS DISCOVERED DURING THE ROUTINE CHECKUP AND DID NOT CAUSE ANY PAINFUL ISSUES NECESSITATING IMMEDIATE REVISION SURGERY.DESPITE THESE DEVELOPMENTS, THE STRUCTURE REMAINED STABLE, AIDED BY THE STRONG BONE HEALING. AS A RESULT, NO REVISION SURGERY WAS RECOMMENDED. THE PATIENT'S HARDWARE REMOVAL WAS SCHEDULED AS INITIALLY PLANNED, AND THERE WERE NO REPORTED COMPLICATIONS DURING THIS PROCEDURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
89537 FINE OSTEOTOMY FINE OSTEOTOMY HRS BODYCAD LABORATORIES INC, 15000 00688346002140

Patients

Seq Age Sex Outcome Treatment
1 36 YR Male