FDA Adverse Event
Injury
Summary report: N
TRIDENT 0X3 INSERT 32 MM ID
MDR report key: 1810002
·
Received August 12, 2010
Report
- Report Number
- 2249697-2010-01094
- Event Type
- Injury
- Date Received
- August 12, 2010
- Date of Event
- July 19, 2010
- Report Date
- July 20, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K033716
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR #S 2249697-2010-01093, 01095 & 01096.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "PT PRESENTED WITH (B)(6) INFECTION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 0X3 INSERT 32 MM ID | IMPLANT | LPH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other| R |