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 2011-11-14 for NUVASIVE SPINOUS PROCESS PLATE SYSTEM UNK manufactured by Nuvasive, Inc..
[19367130]
A spinous process plate was reportedly implanted (b)(6), 2011. The patient reported increasing back pain during a follow-up visit approximately 6 weeks following surgery. At that time it was determined the plate had loosened. No additional information has been available to investigate further. It is unknown if revision surgery has occurred. Patient information and product identification has not been available to date.
Patient Sequence No: 1, Text Type: D, B5
[19377801]
(b)(4). No other information is unknown with respect to patient age, diagnosis, bone integrity, spine level affected, need for additional intervention, etc. The reported event has not been verified via radiography or other means. Product identification is pending. Root cause of the reported event has not been identified. When additional relevant information becomes known, a subsequent report will be filed. Review of labeling notes: "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... "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031966-2011-00052 |
| MDR Report Key | 2380365 |
| Report Source | 05,06,07 |
| Date Received | 2011-11-14 |
| Date of Report | 2011-11-14 |
| Date of Event | 2011-08-10 |
| Report Date | 2011-11-14 |
| Date Mfgr Received | 2011-10-14 |
| Date Added to Maude | 2012-07-13 |
| 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 | PAUL HOLBROOK |
| Manufacturer Street | 7475 LUSK BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8583205285 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVE SPINOUS PROCESS PLATE SYSTEM |
| Generic Name | SPINAL INTERLAMINAL FIXATION ORTHOSIS |
| Product Code | PEK |
| Date Received | 2011-11-14 |
| Model Number | UNK |
| Lot Number | UNK |
| 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 | 2011-11-14 |