FDA Adverse Event
Malfunction
Summary report: N
TRIDENT ACET WINDOW TRIAL 54 MM
MDR report key: 2050573
·
Received March 15, 2011
Report
- Report Number
- 2249697-2011-00318
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 10, 2011
- Report Date
- February 18, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME EVENT AS: MFR # 2249697-2011-00319.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "HOSPITAL WASHED INST IN TOR." ADD'L INFO: SALES REP EXPLAINED THAT THE DEVICES WERE CLEANED IN A LIQUID NAMED "TOR HB", AND THAT THIS SUBSTANCE DEGRADED THE INSTRUMENTS, MAINLY THE PLASTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT ACET WINDOW TRIAL 54 MM | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | 93847601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |