MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for XIA TITANIUM 4.5 ROD ROTATION FORCEPS 48130100 manufactured by Stryker Spine-us.
[113004496]
It was reported that while turning the rod, the rotation key and forceps broke. The surgery was completed successfully with alternate tools in the surgery room. No adverse consequences to the patient were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009617544-2018-00156 |
| MDR Report Key | 7642887 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2013-05-14 |
| Date Added to Maude | 2018-06-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RAKSHYA BISTA |
| 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 ROD ROTATION FORCEPS |
| Generic Name | INSTRUMENT, SURGICAL, NON-POWERED |
| Product Code | HAO |
| Date Received | 2018-06-27 |
| Returned To Mfg | 2018-06-21 |
| Model Number | 48130100 |
| Catalog Number | 48130100 |
| Lot Number | 132164 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-06-27 |