MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for UNKNOWN_SPINE_PRODUCT UNK_SPN manufactured by Stryker Spine-us.
[107463697]
It was reported that a patient had a procedure on (b)(6) 2016 for adolescent scoliosis correction. Surgery went well, correction obtained with no complication. Screws placed t3-l3. Patient was brought back for surgery (b)(6) 2018 due to l3 left sided screw backed out and potential cause of pain. Surgeon decided to remove all instrumentation as the spine has fused and instrumentation no longer needed. On removing the screws, one of the screws was found broken. This caused no issue to the patient and wasn't the reason for the revision surgery. The patient had a total of 21 screws in originally. One screw had backed out and one screw was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2018-00101 |
| MDR Report Key | 7483032 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-06-18 |
| Date Added to Maude | 2018-05-03 |
| 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 | MR. MARTA KOUTSOGIANNIS |
| 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 | 0 |
| Brand Name | UNKNOWN_SPINE_PRODUCT |
| Generic Name | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
| Product Code | OSH |
| Date Received | 2018-05-03 |
| 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 | 2018-05-03 |