FDA Adverse Event
Injury
Summary report: N
T3 MD RV HP MCREYNOLDS ADAPTER
MDR report key: 1221909
·
Received November 4, 2008
Report
- Report Number
- 2249697-2008-00344
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- October 7, 2008
- Report Date
- October 9, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "EXTRACTOR WAS THREADED INTO RESTORATION MODULAR CONICAL STEM FOR REMOVAL AND ATTACHED TO SLAPHAMMER EXTRACTOR. AFTER SEVERAL ATTEMPTS TO EXTRACT THE STEM THE ADAPTER BROKE OFF INSIDE THE STEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | T3 MD RV HP MCREYNOLDS ADAPTER | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | TACGA17 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |