FDA Adverse Event
Malfunction
Summary report: N
TRIDENT 0 DEG X3 INSERT 32MM HEAD
MDR report key: 1872224
·
Received October 13, 2010
Report
- Report Number
- 2249697-2010-01342
- Event Type
- Malfunction
- Date Received
- October 13, 2010
- Date of Event
- September 20, 2010
- Report Date
- September 20, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LZO
- PMA / PMN Number
- K033716
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- 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 AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "WENT TO OPEN IMPLANT BOX AND OUTER BLISTER PACK WAS CRUSHED. BOX APPEARED TO HAVE A HOLE IN IT. WAS UNSURE SO, DID NOT TAKE A CHANCE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 0 DEG X3 INSERT 32MM HEAD | IMPLANT | LZO | STRYKER ORTHOPAEDICS MAHWAH | NA | MJLH7E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |