FDA Adverse Event
Malfunction
Summary report: N
ORTHOLOC(TM) LOW-PROFILE CORTICAL SCREW
MDR report key: 2192061
·
Received August 4, 2011
Report
- Report Number
- 1043534-2011-00394
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- April 22, 2011
- Report Date
- August 4, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HRS
- PMA / PMN Number
- K102429
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO IMPACT OR CONSEQUENCE TO THE PATIENT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PRODUCT WAS NOT RETURNED.
Description of Event or Problem · 1
ALLEGEDLY THE SCREW BROKE AT THE HEAD IN COMPRESSION SLOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOLOC(TM) LOW-PROFILE CORTICAL SCREW | SMALL JOINT COMPONENT | HRS | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |