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 2014-01-17 for SPHERX DEFORMITY SYSTEM 8456045 NA manufactured by Nuvasive, Inc..
[4068038]
The spherx deformity pedicle screws reportedly pulled out of bone post-operatively. The initial posterior lumbar fusion was performed on (b)(6) 2013 involving a construct from l4-s1 bilaterally. On (b)(6) 2013 during routine follow up, it was discovered that the pedicle bone screws at l4 had pulled out bilaterally. The patient was asymptomatic. Revision surgery was performed on (b)(6) 2013 and larger pedicle screw were place. The construct was extended to the l3 vertebral body and a tlif was performed at l4-l5. The patient had poor bone integrity, which continued to degrade. Second revision occurred on (b)(6) 2013 and is filed under 2031966-2013-00094.
Patient Sequence No: 1, Text Type: D, B5
[11532387]
Bone screw pull out. Review of the radiograph confirm the bone screws pullouts from the l4 pedicle. First revision occurred on (b)(6) 2013 to replace the l4 pedicle screws with larger screws for better bone purchase. The construct was extended cranially to l3 with additional screws. No product evaluation can be completed at this time as the implants were discarded by user facility. The patient had poor bone integrity, which continued to degrade. The root cause of this reported event has not been determined, no conclusion can be drawn. However, bone quality may be a contributing factor. Review of labeling notes; "contra-indications include but are not limited to... 5. Patients with inadequate bone stock or quality. " warning, cautions and precautions - product labeling indicates "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031966-2013-00093 |
| MDR Report Key | 3601630 |
| Report Source | 05,06,07 |
| Date Received | 2014-01-17 |
| Date of Report | 2014-01-17 |
| Date of Event | 2013-09-19 |
| Date Facility Aware | 2013-09-19 |
| Report Date | 2014-01-17 |
| Date Mfgr Received | 2013-12-19 |
| Date Added to Maude | 2014-03-07 |
| 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 | 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 | 2014-01-17 |
| Model Number | 8456045 |
| Catalog Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| 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 | 2014-01-17 |