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 2015-02-18 for NUVASIVE HELIX-T ACP SYSTEM 7739217 NA manufactured by Nuvasive, Inc..
[15895386]
The initial two level acdf was performed on (b)(6) 2014 to fuse c3-c5 vertebral bodies. During a follow up visit it was noted that the caudal bone screw at c5 had separated from the plate and was noted to be deeply embedded in the vertebral body. Revision surgery was performed on (b)(6) 2015 and the bone screw was easily removed and replaced. The patient is reportedly doing well post revision surgery. Patient's activity level, compliance with post-surgical instructions and bone integrity are unknown.
Patient Sequence No: 1, Text Type: D, B5
[16020118]
(b)(4). Radiographs received confirmed the event. Evaluation of the returned bone screw displays distortion of the washing collapsed upon the head of the screw. The washer condition is a result of the screw and washer passing through the plate. Review of the device history records notes no material non-conformance's or manufacturing errors that may have caused or contributed to this mode of failure. The depth of the bone screw in the vertebral body was unusual. It is unknown if the depth was a result of initial placement or post-operative separation. Patient impact/sustained fall, poor bone quality 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 | 2031966-2015-00003 |
| MDR Report Key | 4550828 |
| Report Source | 05,06,07 |
| Date Received | 2015-02-18 |
| Date of Report | 2015-02-18 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-01-20 |
| Device Manufacturer Date | 2013-05-17 |
| Date Added to Maude | 2015-03-26 |
| 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 | 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 | NUVASIVE HELIX-T ACP SYSTEM |
| Generic Name | SPINAL INT VERT BODY FIXATION APPLIA |
| Product Code | JDN |
| Date Received | 2015-02-18 |
| Returned To Mfg | 2015-02-12 |
| Model Number | 7739217 |
| Catalog Number | NA |
| Lot Number | NM1711 |
| Device Availability | Y |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-18 |