MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM 482316540 manufactured by Stryker Spine-us.
[110461792]
It is reported that during a revision surgery a screw broke. The broken screw was left inside the patient. Revision surgery was performed due to patient factor: adjacent intervertebral disorders, extension was performed on l2 to s1. No adverse consequences has been reported due to screw breakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2018-00135 |
| MDR Report Key | 7572788 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-05-11 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2015-05-20 |
| Date Added to Maude | 2018-06-06 |
| 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. MARGARITA KARAN |
| 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 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM |
| Generic Name | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
| Product Code | OSH |
| Date Received | 2018-06-06 |
| Returned To Mfg | 2018-06-26 |
| Catalog Number | 482316540 |
| Lot Number | B53478 |
| Device Availability | R |
| 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 | 2018-06-06 |