FDA Adverse Event
Injury
Summary report: N
TRUE POSITION LORDOTIC SPACER
MDR report key: 2934543
·
Received January 28, 2013
Report
- Report Number
- 3003855635-2013-00001
- Event Type
- Injury
- Date Received
- January 28, 2013
- Report Date
- January 28, 2013
- Manufacturer
- ATLAS SPINE, INC.
- Product Code
- KWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
EMAIL REC'D FROM DISTRIBUTOR INDICATING SURGEON HAD AN IMPLANT MIGRATION INSTANCE. SUBSEQUENT X-RAYS INDICATED IMPLANT ROTATED AND EXPULSED POSTERIORLY. SURGEON NOTED THAT THE IMPLANT MAY HAVE BEEN UNDERSIZED, WHICH COULD HAVE RESULTED IN THE EXPULSION. PT WAS COMPLAINING OF LEG PAIN AS A RESULT OF IMPINGEMENT AND A REVISION SURGERY OCCURRED TO RE-POSITION IMPLANT. PT HAS NOT HAD ANY FURTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38215 | TRUE POSITION LORDOTIC SPACER | INTERVERTEBRAL BODY FUSION DEVICE | KWQ | ATLAS SPINE, INC. | 70217-XXX | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |