FDA Adverse Event
Malfunction
Summary report: N
ROD FOR STRAIGHT CUP HOLDER
MDR report key: 2110173
·
Received May 19, 2011
Report
- Report Number
- 9616680-2011-00311
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 27, 2011
- Report Date
- April 27, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "DURING NORMAL IMPACTION OF CUP, THE KNOB OF THE ROD DISASSOCIATED FROM THE ROD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROD FOR STRAIGHT CUP HOLDER | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |