FDA Adverse Event
Injury
Summary report: N
VERTE-STACK® SPINAL SYSTEM
MDR report key: 2110594
·
Received June 1, 2011
Report
- Report Number
- 1030489-2011-00652
- Event Type
- Injury
- Date Received
- June 1, 2011
- Report Date
- May 2, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- MQP
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION PROCEDURE. AN UNKNOWN TIME POST-OP, THERE WAS A NON UNION AT THE INSTRUMENTED LEVEL, THE INTERBODY CAGE SUNK INTO THE VERTEBRAL BODY. THE PATIENT UNDERWENT A REVISION SURGERY. EVERYTHING WAS REMOVED ALTHOUGH PATIENT HAD NO COMPLAINTS, ILIAC CREST GRAFT WAS THEN INSERTED AT THE EXPLANTED LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTE-STACK® SPINAL SYSTEM | MQP | MEDTRONIC SOFAMOR DANEK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |