MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-23 for XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM 48232601 manufactured by Stryker Spine-switzerland.
[32130195]
It was reported that the rod broke upon bending.
Patient Sequence No: 1, Text Type: D, B5
[36364760]
Lot# m8v. Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the returned rod was confirmed to have fractured at the laser marking dot. The laser marking dot was inspected using a microscope and voids were identified. These voids can act as stress risers when placed on the tensile side of the bend, which they were in this case. Conclusion: the most likely cause of the customer reported event is the presence of voids on the laser marking dot, as a result of the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
[36364761]
It was reported that the rod broke upon bending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005525032-2015-00136 |
| MDR Report Key | 5243450 |
| Date Received | 2015-11-23 |
| Date of Report | 2015-10-30 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2015-10-30 |
| Device Manufacturer Date | 2015-07-02 |
| Date Added to Maude | 2015-11-23 |
| 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 | MS. CHRISTA MARROW |
| 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 VITALIUM ROD WITH HEX 6.0MM X 600MM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | OSH |
| Date Received | 2015-11-23 |
| Catalog Number | 48232601 |
| Lot Number | M8V |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SPINE-SWITZERLAND |
| Manufacturer Address | LE CR?T-DU-LOCLE 10 A - LA CHAUX-DE-FONDS 2300 CH 2300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-23 |