FDA Adverse Event
Malfunction
Summary report: N
CENTRAX DURATION 26MM X 41MM
MDR report key: 2220596
·
Received July 15, 2011
Report
- Report Number
- 2249697-2011-01060
- Event Type
- Malfunction
- Date Received
- July 15, 2011
- Date of Event
- May 31, 2011
- Report Date
- June 23, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K780317
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THERE WAS A GAP (1.5MM) BETWEEN THE LOCKING RING AND METAL SHELL. WHEN THE SURGEON PUSHED ON THE LOCKING RING TO FILL A GAP, THE CENTRAX CLICKED. HE FELT THAT THE LOCKING WAS TOO LOOSE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRAX DURATION 26MM X 41MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | A10H424 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |