FDA Adverse Event
Injury
Summary report: N
CLAVICLE PLATING SYSTEM
MDR report key: 1841085
·
Received September 15, 2010
Report
- Report Number
- 3005039508-2010-00016
- Event Type
- Injury
- Date Received
- September 15, 2010
- Date of Event
- August 20, 2010
- Report Date
- August 20, 2010
- Manufacturer
- ORTHOHELIX SURGICAL DESIGN
- Product Code
- HRS
- PMA / PMN Number
- K090289
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PLATE WEAR IS CONSISTENT WITH CYCLIC LOADING ON THE IMPLANT, PLATE BROKE THROUGH A SCREW HOLE AT THE TRI-LOBE FEATURE. THE THREADS ON THE HEAD OF THE SCREW THROUGH THE BROKEN HOLE WERE WORN DOWN TO NUBS, WHICH IS ALSO INDICATIVE OF CYCLIC LOADING. PER THE PRODUCT IFU, "POST-OPERATIVE CARE NOTE: POSTOPERATIVE CARE IS EXTREMELY IMPORTANT. THE PATIENT MUST BE WARNED THAT NONCOMPLIANCE WITH POSTOPERATIVE INSTRUCTIONS COULD LEAD TO BREAKAGE OF THE IMPLANT REQUIRING REVISION SURGERY TO REMOVE THE DEVICE."
Description of Event or Problem · 1
A SUPERIOR PLATE BROKE IN A NONUNION, 1 YEAR POST-OP, WITH A YOUNG PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLAVICLE PLATING SYSTEM | BONE FIXATION PLATES AND SCREWS | HRS | ORTHOHELIX SURGICAL DESIGN | CLA-002-LATXR | 1019031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |