MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-11-26 for manufactured by Synthes (usa).
[4013554]
It was reported that a patient was treated with a l3-s1 posterior lumbar fusion using uss dual opening pedicle screws and mtf transforaminal-posterior lumbar interbody fusion allograft spacers on (b)(6) 2013. The patient reportedly had a fall on an unknown date following the procedure, and reported to the surgeon with back pain. Examination on an unknown date by the surgeon revealed the patient had fractured the l3 pedicles and developed a kyphotic deformity in the l2-l3 area above the hardware, and the l3 screws appeared to be pulling out posteriorly due to the l3 fractures. In addition, the transforaminal-posterior lumbar interbody fusion allograft spacers spacer at the l3-l4 disc space had migrated posteriorly out of the disc space. Surgeon returned the patient to the operating room on (b)(6) 2013 for revision surgery. He retrieved the allograft spacer that had been placed at l3-l4, and removed all the uss dual opening hardware. He then instrumented the patient from t10-s1 with synthes uss dual opening pedicle screws, skipping the l2 level where he performed a modified pedicle subtraction osteotomy to address the patient's kyphosis. He also replaced the transforaminal-posterior lumbar interbody fusion allograft spacers at l3-l4 level, and connected the rods and successfully completed the procedure. This report is for 8 unknown screws. This is report 1 of 18 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11296284]
Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. This report is for 8 unknown screws/unknown lot. Partial information provided: 499. 2xx uss dual opening screws-unknown sizes. Device was used for treatment, not diagnosis. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-07505 |
| MDR Report Key | 3489579 |
| Report Source | 05,07 |
| Date Received | 2013-11-26 |
| Date of Report | 2013-11-05 |
| Date Mfgr Received | 2013-11-05 |
| Date Added to Maude | 2013-11-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TRACY GUTIERREZ |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | MCV |
| Date Received | 2013-11-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-26 |