MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-11-16 for UNKNOWN_SPINE_PRODUCT UNK_SPN manufactured by Stryker Spine-us.
[31270525]
It was reported that in (b)(6) 2015, es2 primary surgery was performed. After that, neurological symptoms appeared due to the protrusion of l5 left side screw to medial. Therefore revision surgery is planned in the near future.
Patient Sequence No: 1, Text Type: D, B5
[36489446]
Method: risk assessment; results: additional information such as xrays from the original surgery and the patient's health and lifestyle were not reported. Conclusion: the most likely cause of the reported event is not determined and multifactorial.
Patient Sequence No: 1, Text Type: N, H10
[36489447]
It was reported that in (b)(6) 2015, es2 primary surgery was performed. After that, neurological symptoms appeared due to the protrusion of l5 left side screw to medial. Therefore revision surgery is planned in the near future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004024955-2015-00092 |
| MDR Report Key | 5225276 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-11-16 |
| Date of Report | 2015-10-21 |
| Date of Event | 2015-10-21 |
| Date Mfgr Received | 2015-10-21 |
| Date Added to Maude | 2015-11-16 |
| 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-US |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_SPINE_PRODUCT |
| Generic Name | UNK |
| Product Code | JDN |
| Date Received | 2015-11-16 |
| 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-US |
| Manufacturer Address | 2 PEARL COURT ALLENDALE NJ 07401 US 07401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-16 |