MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-23 for UNKNOWN_SPINE_PRODUCT UNK_SPN manufactured by Stryker Spine-france.
[26568375]
It was reported that; the patient underwent the surgery. However, infection was seen after surgery. Therefore, the surgeon removed the all implants.
Patient Sequence No: 1, Text Type: D, B5
[32310787]
Method: device history review; complaint history review; risk assessment;results: no new hazards or harms were found. Manufacturing records could not be reviewed because no parts or lot number were provided. Conclusion: the patient was reported to have an infection due to the implants, so the probable cause of the screw backout is patient reaction.
Patient Sequence No: 1, Text Type: N, H10
[32310788]
It was reported that; the patient underwent the surgery. However, infection was seen after surgery. Therefore, the surgeon removed the all implants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2015-00416 |
| MDR Report Key | 5098178 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-23 |
| Date of Report | 2015-08-26 |
| Date of Event | 2015-08-26 |
| Date Mfgr Received | 2015-08-26 |
| Date Added to Maude | 2015-09-23 |
| 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 | 2015-09-23 |
| Catalog Number | UNK_SPN |
| 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 | 2015-09-23 |