N
Patient 1
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
MAUDE MDR 9898284
- MDR report key
- 9898284
- Report number
- 2916714-2020-00076
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-10
- Date received
- 2020-03-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- D
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COLLECT.NO.QAS SPINE SPINAL MOTION | ACTIV L IMPLANTS | AESCULAP AG | MJO | AE-QAS-SP44 | AE-QAS-SP44 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-30 | 0 | 1. O; 2. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN ACTIV L IMPLANT. IT WAS NOTED THAT DURING THE ORIGINAL IMPLANTATION OF THE ACTIVL DEVICE, THE SURGEON WAS NOT ABLE TO GET DIRECT ALIGNMENT WITH THE MIDLINE DUE TO LIMITED EXPOSURE. POSTOPERATIVELY , THE PATIENT COMPLAINED OF LEG PAIN AFTER 5 MONTH. THE X-RAY RESULTS SHOWED THAT THE IMPLANT HAD MIGRATED TO THE LEFT SIDE OFF THE MIDLINE WHICH CAUSED BACK PAIN. IT WAS NOTED THAT THE PATIENT WAS NOT INVOLVED IN ANY EXTRANEOUS ACTIVITY; HOWEVER, THE PATIENT WAS SMOKING AND NOT FOLLOWING INSTRUCTIONS. THE EXPLANT SURGERY WAS POSTPONED DUE TO THE PATIENT 'S "NON-COMPLIANT" BEHAVIOR. THE REVISION SURGERY WAS DELAYED INDEFINITELY. ADDITIONAL INFORMATION WAS REQUESTED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).