FDA Adverse Event
Injury
Summary report: N
4.5MM CANNULATED SCREW, FULLY THREADED
MDR report key: 2032587
·
Received March 23, 2011
Report
- Report Number
- 2520274-2011-00072
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 9, 2011
- Manufacturer
- SYNTHES (USA)
- Product Code
- HWC
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. MANUFACTURE SITE AND MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER. COULD NOT BE DETERMINED WITHOUT A CATALOG NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
PATIENT IMPLANTED WITH 4.5MM FULLY THREADED CANNULATED SCREWS DURING TALO-NAVICULAR FUSION ON AN UNKNOWN DATE WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL AND REVISION TO PARTIALLY THREADED SCREWS. X-RAY FOUND TWO SCREWS BROKEN POST OPERATIVE. PATIENT WAS HEALING. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.5MM CANNULATED SCREW, FULLY THREADED | CANNULATED SCREWS | HWC | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |