FDA Adverse Event
Injury
Summary report: N
UNKNOWN CERCLAGE WIRE
MDR report key: 7588854
·
Received June 11, 2018
Report
- Report Number
- 0002249697-2018-01772
- Event Type
- Injury
- Date Received
- June 11, 2018
- Date of Event
- May 1, 2012
- Report Date
- June 11, 2018
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- HXN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED.
Description of Event or Problem · 1
AT THE BEGINNING OF (B)(6) 2012 HE WAS SUBJECTED TO THE REMOVAL OF THE METALLIC CERCLAGE MOBILIZED IN THE MEANTIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427808 | UNKNOWN CERCLAGE WIRE | UNKNOWN HIP IMPLANT | HXN | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| O| R |