MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-06 for XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 30 48144530 manufactured by Stryker Spine-us.
[116206554]
Device was not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[116206555]
It was reported that the surgeon was removing screws and the patient lost motor and ssep monitoring. A screw appeared to be cold welded with the tulip stuck to the screw shank in an angled position. The surgeon was able to remove the tulip and screw from the patient. The case has been aborted. Upon follow up, it was reported that the patient had a neurological deficit on one leg post operatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2018-00188 |
| MDR Report Key | 7754513 |
| Date Received | 2018-08-06 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-08-06 |
| 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 | 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 | XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 30 |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS |
| Product Code | OSH |
| Date Received | 2018-08-06 |
| Catalog Number | 48144530 |
| 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-US |
| Manufacturer Address | 2 PEARL COURT ALLENDALE NJ 07401 US 07401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-06 |