MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-09-22 for LAMINOPLASTY FIXATION SYSTEM 7650108 N/A manufactured by Nuvasive, Inc..
[26424649]
No radiographs were received and the event could not be confirmed. The implants were discarded by the hospital, no product information given and no further product investigation can be completed at this time. It is unknown if the patient complied with post-operative care instructions. The patient reportedly fell prior to the event, but it is unknown if this contributed to the event. Root cause has not been determined, no conclusion can be drawn. 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, fracture of the vertebra, and vascular or visceral injury. If healing is delayed, or does not occur, the implant may eventually loosen, bend or break. Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant". Implants were discarded by the hospital.
Patient Sequence No: 1, Text Type: N, H10
[26424650]
Laminoplasty fixation system was implanted on (b)(6) 2015 in a (b)(6) female at c3. On (b)(6) 2015 the patient sustained a fall and was revised on (b)(6) 2015 for a lamina fracture. Patient is stable and is doing well post-revision. Implants were discarded by the hospital. No malfunction of the construct occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2015-00053 |
| MDR Report Key | 5094001 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-09-22 |
| Date of Report | 2015-09-22 |
| Date of Event | 2015-09-02 |
| Date Mfgr Received | 2015-09-01 |
| Date Added to Maude | 2015-09-22 |
| 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 | MS. DEBORAH SILVA |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8589091830 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAMINOPLASTY FIXATION SYSTEM |
| Generic Name | ORTHOSIS, SPINE, PLATE. LAMINOPLSTY METAL |
| Product Code | NQW |
| Date Received | 2015-09-22 |
| Model Number | 7650108 |
| Catalog Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization | 2015-09-22 |