FDA Adverse Event
Malfunction
Summary report: N
SIMPLEX HV WITH GENTAMICIN US 1 PACK
MDR report key: 6369134
·
Received March 1, 2017
Report
- Report Number
- 0002249697-2017-00712
- Event Type
- Malfunction
- Date Received
- March 1, 2017
- Date of Event
- January 31, 2017
- Report Date
- September 11, 2017
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LOD
- PMA / PMN Number
- K123081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS INITIALLY FILED FOR UNKNOWN SIMPLEX. IT WAS LATER DISCOVERED THAT THIS WAS A DUPLICATE OF ANOTHER REPORT FOR SIMPLEX HV. STRYKER ORTHOPAEDICS IS A DISTRIBUTOR OF THIS DEVICE, WHICH IS MANUFACTURED BY AAP. THE MANUFACTURER IS RESPONSIBLE FOR REGULATORY DECISIONS UNDER MDR/MDV AND SUBMITTING ANY REQUIRED MDR/MDV REPORTS. SUPPLIER HAS BEEN NOTIFIED.
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
GLASS VIAL TOP BROKE UNEVENLY.
Description of Event or Problem · 1
GLASS VIAL TOP BROKE UNEVENLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150309 | SIMPLEX HV WITH GENTAMICIN US 1 PACK | BONE CEMENT | LOD | STRYKER ORTHOPAEDICS-MAHWAH | 605BA949KW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |