MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-17 for 7.0MM TI SIDE-OPENING SCREW 45MM 498.745 manufactured by Synthes Usa.
[3968799]
Consultant reported patient was implanted with synthes universal spine system (synthes uss) for an l4-l5 posterior fusion on an unknown date in (b)(6) 2012. The patient returned to the surgeon on an unknown date complaining of experiencing back pain. The surgeon determined that the patient had adjacent level stenosis at l3-l4 level in addition to a non-union at l4-l5. There were no issues with the hardware. On (b)(6) 2013, surgeon returned the patient to the operating room and removed all the synthes universal spine system hardware, and re-instrumented the patient with new synthes universal spine system hardware at the l4-l5 level and placed screws at l3. He performed a decompression at the l3-l4 level and placed an mtf transforaminal posterior lumbar interbody fusion (t-plif) allograft at that level. Surgeon then placed and connected the rods from l3-l5 and successfully completed the procedure. No report of delay in surgery or harm to patient. No additional information available. This is report 2 of 14 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11305566]
The device is used for treatment, not diagnosis. Additional product codes: mni, mnh, kwp, kwq. Part lot # is unknown. Date received by manufacturer (b)(4) 2013. Investigation could not be completed and no conclusion could be drawn as no device will be returned and no part lot number is provided. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-07836 |
| MDR Report Key | 3522865 |
| Report Source | 05,07 |
| Date Received | 2013-12-17 |
| Date of Report | 2013-11-19 |
| Date Mfgr Received | 2013-11-19 |
| Date Added to Maude | 2013-12-17 |
| 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 | MS. DEIDRE ADORE |
| 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 |
| Brand Name | 7.0MM TI SIDE-OPENING SCREW 45MM |
| Product Code | KWO |
| Date Received | 2013-12-17 |
| Catalog Number | 498.745 |
| 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 | 2013-12-17 |