MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-03 for UNKNOWN_SPINE_PRODUCT UNK_SPN manufactured by Stryker Spine-france.
[30330950]
It was reported that; rods broken implanted into my spine. Both (2) will need to be replaced.
Patient Sequence No: 1, Text Type: D, B5
[33412846]
Method: no methods performed because device was no properly identified and not returned. Results: no results available because no methods were performed. Conclusion: the root cause of the reported event could not be determined because no device and/or insufficient information were provided for review.
Patient Sequence No: 1, Text Type: N, H10
[33412847]
It was reported that; rods broken implanted into my spine. Both (2) will need to be replaced.
Patient Sequence No: 1, Text Type: D, B5
[53735803]
Method: device history review. Device not returned. Results: device history and complaint history could not be performed as the reported device was no properly identified. Images provided for review show two fractured rods. No cat/lot numbers can be identified from the images provided. The patient had several risk factors for the non-union, including a history of smoking, marijuana use, hepatitis c and direct trauma to his surgery site. Spinal fusion hardware is designed to hold the fracture together as it heals. It serves as a temporary fixation device. However, if union, or fusion, does not take place, it can result in the hardware breaking. Conclusion: the event was confirmed. Per clinical consultant's medical review; the non-union caused the fracture of the rods.
Patient Sequence No: 1, Text Type: N, H10
[53735804]
It was reported that; rods broken implanted into my spine. Both (2) will need to be replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2015-00470 |
| MDR Report Key | 5199316 |
| Date Received | 2015-11-03 |
| Date of Report | 2015-10-10 |
| Date of Event | 2015-09-16 |
| Date Mfgr Received | 2015-10-10 |
| Date Added to Maude | 2015-11-03 |
| 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. CHRISTA MARROW |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608000 |
| Manufacturer G1 | STRYKER SPINE-FRANCE |
| Manufacturer Street | ZONE INDUSTRIELLE DE MARTICOT |
| Manufacturer City | CESTAS 33610 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_SPINE_PRODUCT |
| Generic Name | UNKNOWN SPINE PRODUCT |
| Product Code | JDN |
| Date Received | 2015-11-03 |
| Catalog Number | UNK_SPN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SPINE-FRANCE |
| Manufacturer Address | ZONE INDUSTRIELLE DE MARTICOT CESTAS 33610 FR 33610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-03 |