FDA Adverse Event
Malfunction
Summary report: N
MIS DISTAL RESECTION GUIDE RT
MDR report key: 1951282
·
Received December 14, 2010
Report
- Report Number
- 2249697-2010-01729
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- November 17, 2010
- Report Date
- November 18, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR# 2249697-2010-01730.
Description of Event or Problem · 1
THE ALLEGED EVENT HAS BEEN REPORTED BY (B)(6), DISTRIBUTOR FROM (B)(4) COMPANY: THE DEVICES WERE JAMMED INTO THE GUIDES DURING A TOTAL KNEE PROSTHESIS SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIS DISTAL RESECTION GUIDE RT | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |