FDA Adverse Event
Malfunction
Summary report: N
D-M 2.0MM BEADED CABLE SET VIT
MDR report key: 3880017
·
Received June 18, 2014
Report
- Report Number
- 0002249697-2014-02350
- Event Type
- Malfunction
- Date Received
- June 18, 2014
- Date of Event
- May 23, 2014
- Report Date
- May 29, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDQ
- PMA / PMN Number
- K953818
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THE TENSIONOR COULD NOT TENSION THE CABLE PROPERLY. SPARE TENSIONOR AND CABLE WERE USED INSTEAD OF THEM, AND THE PROCEDURE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 357321 | D-M 2.0MM BEADED CABLE SET VIT | IMPLANT | JDQ | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |