FDA Adverse Event
Malfunction
Summary report: N
CAPSTONE CONTROL¿ SPINAL SYSTEM
MDR report key: 3972976
·
Received August 1, 2014
Report
- Report Number
- 1030489-2014-03379
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
- Product Code
- MAX
- PMA / PMN Number
- K120368
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBER INTERBODY FUSION (PLIF). THE FIXED LEVEL WAS UNKNOWN. AFTER THE OPERATION, A SUBSIDENCE OF A CAGE WAS FOUND, SO A REVISION SURGERY IS TO BE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451742 | CAPSTONE CONTROL¿ SPINAL SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR | Required Intervention |