FDA Adverse Event
Malfunction
Summary report: N
MOTOBAND CP IMPLANT SYSTEM
MDR report key: 15714778
·
Received November 2, 2022
Report
- Report Number
- 3020584246-2022-00059
- Event Type
- Malfunction
- Date Received
- November 2, 2022
- Date of Event
- September 12, 2022
- Report Date
- November 2, 2022
- Manufacturer
- CROSSROADS EXTREMITY SYSTEM, LLC
- Product Code
- HRS
- PMA / PMN Number
- K193452
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE SURGEON REPORTS THAT 6-8 MONTHS AFTER THE ORIGINAL SURGERY, THE DYNABUNION PLATE APPEARS TO HAVE SHIFTED AND MOTOBAND BONE SCREWS AT THE PROXIMAL END OF THE PLATE HAVE BACKED OUT. THE ANTIDRIFT BOLT (ADB) APPEARS TO HAVE PULL-THROUGH THE PLATE, ALTHOUGH THE SURGEON STATES THAT THE PLATE HAS MIGRATED AS OPPOSED TO THE ADB. THE SURGEON STATES THAT THE PATIENT HAS A NON-UNION, POTENTIALLY DUE TO NON-COMPLIANCE AFTER THE INITIAL SURGERY REGARDING WEARING BOOT AND RETURN TO FULL ACTIVITY. THE SURGEON IDENTIFIED THE PATIENT HAD HETEROTROPIC OSSIFICATION AROUND PLAT WITH SOFT TISSUE SCARRING. THE PATIENT REPORTS VERY LIMITED, ALMOST NO PAIN AT FOLLOW-UP WHERE MIGRATION IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2874977 | MOTOBAND CP IMPLANT SYSTEM | PLATE | HRS | CROSSROADS EXTREMITY SYSTEM, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |