MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 600MM 48233600 manufactured by Stryker Spine-us.
[186591525]
Status and location of the device is unknown.
Patient Sequence No: 1, Text Type: N, H10
[186591526]
It was reported that two xia 3 titanium rods fractured post-operatively. Revision surgery was performed and the rods were exchanged. This report represents the first of the two rods.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2020-00048 |
| MDR Report Key | 9900712 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-30 |
| 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. RITA 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 | 3 |
| Brand Name | XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 600MM |
| Generic Name | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
| Product Code | NKB |
| Date Received | 2020-03-30 |
| Model Number | 48233600 |
| Catalog Number | 48233600 |
| Lot Number | PBP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-30 |