MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-02-13 for SPHERX DEFORMITY SYSTEM 8456540 NA manufactured by Nuvasive, Inc..
[20125314]
In (b)(6) 2014 patient underwent l4-s1 fusion with tlif at l4/5 with bilateral pedicle screws and rod instrumentation. During routine 3 month follow up it was noted that both the s1 bone screws appeared to have fractured mid shaft. The patient returned (b)(6) 2015 for a tlif revision surgery at l5/s1 and replaced both bone screws. Patient activity level, bone quality, and compliance with post-surgical instructions are known.
Patient Sequence No: 1, Text Type: D, B5
[20281482]
(b)(4). Radiographs received confirmed the event. Evaluation of the fractured surface of the bone screw suggests there was a cyclical fatigue failure. Review of the device history records notes no material non-conformances or manufacturing errors that may have cause or contributed to this mode of failure. Patient impact/sustained fall or other factors contributing to a failure are unknown. The root cause of this reported event has not been determined; no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031966-2015-00002 |
| MDR Report Key | 4532092 |
| Report Source | 05,06,07 |
| Date Received | 2015-02-13 |
| Date of Report | 2015-02-13 |
| Date of Event | 2014-10-01 |
| Date Mfgr Received | 2015-01-17 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2015-03-19 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PETER PERHACH |
| Manufacturer Street | 7475 LUSK BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8589093347 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPHERX DEFORMITY SYSTEM |
| Generic Name | SPINAL PEDICLE SCREW SYSTEM |
| Product Code | JDN |
| Date Received | 2015-02-13 |
| Model Number | 8456540 |
| Catalog Number | NA |
| Lot Number | NU3311 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC. |
| Manufacturer Address | 7475 LUSK BLVD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-13 |