MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-11-28 for XIA 3 TITANIUM BLOCKER 48230000 manufactured by Stryker Spine-us.
[128566884]
It was reported that a lumbar fixation was performed (b)(6) 2018. Patient felt pain after a small walk. After examination through x-ray, doctor found two blockers came out from the tulip head, and a third blocker was found to be loose. Revision surgery was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005525032-2018-00076 |
| MDR Report Key | 8109932 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-10-30 |
| Date Added to Maude | 2018-11-28 |
| 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. KEVIN SMITH |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608000 |
| Manufacturer G1 | STRYKER SPINE-SWITZERLAND |
| Manufacturer Street | LE CR - |
| Manufacturer City | LA CHAUX-DE-FONDS 2300 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XIA 3 TITANIUM BLOCKER |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS |
| Product Code | OSH |
| Date Received | 2018-11-28 |
| Catalog Number | 48230000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-11-28 |