FDA Adverse Event
Injury
Summary report: N
PERI-LOC
MDR report key: 1894098
·
Received November 9, 2010
Report
- Report Number
- 1020279-2010-00317
- Event Type
- Injury
- Date Received
- November 9, 2010
- Date of Event
- October 26, 2010
- Report Date
- November 9, 2010
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HRS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS CONCLUDED THAT THE LOCKING PLATE FRACTURED BY METAL FATIGUE CRACKING. THE CRACK PROPAGATED BY FURTHER METAL FATIGUE LEADING TO AN EVENTUAL FRACTURE OF THE PLATE. FATIGUE CRACKING IS CAUSED BY THE PLATE BEARING CYCLIC (I.E. REPEATED) STRESSES IN EXCESS OF THE MATERIAL ENDURANCE LIMIT FOR AN EXTENDED PERIOD OF TIME. THESE EXCESSIVE CYCLIC STRESSES MAY BE CAUSED BY ANY NUMBER OF CONDITIONS, INCLUDING BUT NOT LIMITED TO (I) POOR BONE QUALITY, (II) EXCESSIVE PATIENT ACTIVITY LEVELS PRIOR TO FULL BONE UNION, AND (III) CHRONIC NON-UNION OR MAL-UNION OF THE BONE FRACTURE. NO MATERIALS OR MANUFACTURING FLAWS WERE FOUND IN THIS INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PLATE BENT REQUIRING A REVISION SURGERY TO CORRECT.
Description of Event or Problem · 1
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERI-LOC | PLATE | HRS | SMITH & NEPHEW, INC. | 05CM14475 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R |