MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-02-06 for N/A manufactured by .
[136135182]
On january 8th, 2019, seaspine was made aware of a complaint filed to (b)(6). The complaint alleges a cracked cervical plate at levels c5-c7. Dhr review and product investigation cannot be completed as no part or lot number have not been identified. No patient information is available. No x-rays or radiographs have been provided. Review of labeling notes: possible adverse events: bending, disassembly or fracture of implant and components. Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain. Postoperative warnings: the patient should be advised that implants may bend, break or loosen despite restriction in activity. The root cause is unknown, as additional information is unavailable. No conclusions can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10
[136135183]
On january 8th, 2019, seaspine was made aware of a complaint filed to (b)(6). The complaint alleges a cracked cervical plate at levels c5-c7. On (b)(6) 2013, the plaintiff had a c5-c7 anterior cervical discectomy fusion with instrumentation performed. On (b)(6) 2016, supposed x-ray performed showed a cracked cervical plate. It is unknown if revision surgery has occurred. It is unknown the current patient condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012120772-2019-00002 |
| MDR Report Key | 8313399 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2013-10-08 |
| Date Mfgr Received | 2019-01-08 |
| Date Added to Maude | 2019-02-06 |
| 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 | AARON |
| Manufacturer Street | 5770 ARMADA DRIVE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | N/A |
| Product Code | JDN |
| Date Received | 2019-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-06 |