MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-13 for UNIVISE SPINOUS PROCESS FIXATION PLATE, 40MM 48590040 manufactured by Stryker Spine-switzerland.
[4056391]
It was reported that initially the univise implant wouldn't compress due to the different thickness of superior and inferior spinous process. Using the compressor and final tightening the device (2 clicks with torque limiting handle) the surgeon was able to achieve a little more compression but was still not confident. Teeth on smaller sp were still not really engaged into the bone. The surgeon loosened, compressed and final tightened again when the implant broke.
Patient Sequence No: 1, Text Type: D, B5
[26796974]
Method: device not returned. Results: the univise spinous process fixation plate, 40mm was confirmed to disassemble during surgery by sales rep report and by a picture of the disassembled device provided by the sales rep. However, three requests for return of the device were made and it was not received. Furthermore, no anomalies were identified in the manufacturing files for the reported lot that may have contributed to the event. Additionally it was reported that the superior and inferior spinous processes that the plate was being attached to were of significantly different thickness. The plates were opening and closing properly, however the plates could not fit to the patient anatomy. This led to excessive force being applied to the device and caused disassembly. Conclusion: this issue is related to improper implant selection and patient anatomy.
Patient Sequence No: 1, Text Type: N, H10
[26796975]
It was reported that initially the univise implant wouldn't compress due to the different thickness of superior and inferior spinous process. Using the compressor and final tightening the device (2 clicks with torque limiting handle) the surgeon was able to achieve a little more compression but was still not confident. Teeth on smaller sp were still not really engaged into the bone. The surgeon loosened, compressed and final tightened again when the implant broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005525032-2014-00012 |
| MDR Report Key | 3570031 |
| Report Source | 06 |
| Date Received | 2014-01-13 |
| Date of Report | 2013-12-17 |
| Date of Event | 2013-12-17 |
| Date Mfgr Received | 2013-12-17 |
| Date Added to Maude | 2014-01-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DANIEL ROBERTS |
| 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 | UNIVISE SPINOUS PROCESS FIXATION PLATE, 40MM |
| Generic Name | IMPLANT- SPINAL PROCESS FIXATION PLATE |
| Product Code | PEK |
| Date Received | 2014-01-13 |
| Catalog Number | 48590040 |
| Lot Number | B34438 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2014-01-13 |