FDA Adverse Event
Malfunction
Summary report: N
EXETER 2.5 I M PLUG 14MM
MDR report key: 2020518
·
Received February 16, 2011
Report
- Report Number
- 9610726-2011-00041
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- January 27, 2011
- Report Date
- February 4, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JDI
- PMA / PMN Number
- K980843
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PLUG BROKE BEFORE IMPLANTATION ON INTRODUCER. THE CUSTOMER FURTHER REPORTED VIA THE SALES REP, THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER SIMILAR PRODUCT WHICH WAS OPENED IMMEDIATELY. CUSTOMER ADDED VIA THE SALES REP THAT NO ADDITIONAL ANAESTHESIA WAS GIVEN TO PT AND HENCE NO ADVERSE CONSEQUENCES FROM THIS, NEITHER WERE THERE DELAYS TO SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER 2.5 I M PLUG 14MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS LIMERICK | NA | L5245 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |