FDA Adverse Event
Malfunction
Summary report: N
ADJUSTABLE SPACER BLOCK
MDR report key: 2050607
·
Received March 15, 2011
Report
- Report Number
- 2249697-2011-00313
- 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
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS: MFR #S 2249697-2011-00310, 00311, 00312, AND 00314.
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 | ADJUSTABLE SPACER BLOCK | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | NZN03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |