FDA Adverse Event
Malfunction
Summary report: N
MRH HDP ASSEMBLY PACK
MDR report key: 2143487
·
Received June 2, 2011
Report
- Report Number
- 9610726-2011-00181
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 17, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- KRO
- PMA / PMN Number
- K994207
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
HEAD PHYSICIAN OF THE HOSPITAL REPORTED TO OUR SALES REP THAT HE WAS PERFORMING A SURGERY PROCEDURE. DURING THIS PROCEDURE NURSE OBSERVED THAT THE BOX OF THE IMPLANT WAS OPEN. SO, THE IMPLANT WASN'T STERILE ANY LONGER. A REPLACEMENT WAS AVAILABLE SO THE SURGEON COULD COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRH HDP ASSEMBLY PACK | IMPLANT | KRO | STRYKER ORTHOPAEDICS LIMERICK | NA | LCD431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other |