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 2014-11-21 for SPHERX DEFORMITY SYSTEM 8252004 NA manufactured by Nuvasive, Inc..
[5081413]
Following the initial surgery at l1-s1 (date unk) the patient underwent adjacent segment fixation (asf) surgery (date unk) to extend the construct from l1 cranially to t6. Radiographic evaluation noted a bilateral fractured rod at t12. Event radiograph also noted a suspected compression fracture of the vertebral body (no bone screw present) at t12. It is unk if the suspected vertebral fracture was the prior to implantation of the asf. The fractured asf rod was revised on (b)(6) 2014. The patient is reportedly doing well post revision surgery. Patient's activity level and compliance with post-surgical instructions are unk.
Patient Sequence No: 1, Text Type: D, B5
[12508126]
Nuvasive reference (b)(4). Radiographs received confirmed the event. Rods were discarded by hosp. No product info was given and no further evaluation of the product can be completed. The construct was a large moment arm (two points supporting 7 levels above and 5 fused levels below) focusing forces at one level - t12. It is unk if fusion has occurred t6-t12. It is unk if the patient sustained some impact or fall. The root cause of this reported event has not been determined; no conclusion can be drawn. Discarded by the hosp.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031966-2014-00078 |
| MDR Report Key | 4305709 |
| Report Source | 05,06,07 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-11-21 |
| Date of Event | 2014-10-21 |
| Date Facility Aware | 2014-10-21 |
| Report Date | 2014-11-21 |
| Date Mfgr Received | 2014-10-23 |
| Date Added to Maude | 2014-12-09 |
| 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 | 3 |
| Event Location | 3 |
| 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 | MCV |
| Date Received | 2014-11-21 |
| Model Number | 8252004 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-21 |