MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-08 for UNIVISE SPINOUS PROCESS FIXATION PLATE, 35MM 48590035 manufactured by Stryker Spine-switzerland.
[4055142]
It was reported that upon implantation, surgeon used a mallet to position the univise implant between the spinous processes. The implant was locked at undesirable angle so he used the inner shaft driver to loosen the implant, repositioned the implant and then proceeded to implant again. Once the surgeon reached a desired position the surgeon used the inner shaft to compress the implant. But the implant would not compress the surgeon then removed the implant. As the surgeon inspected the implant for a cause of the issue the implant ended up separating apart into 3 pieces. Another spinious process fixation device was used and the surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005525032-2014-00008 |
| MDR Report Key | 3561020 |
| Report Source | 07 |
| Date Received | 2014-01-08 |
| Date of Report | 2013-12-12 |
| Date of Event | 2013-12-12 |
| Date Mfgr Received | 2013-12-12 |
| Date Added to Maude | 2014-04-09 |
| 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, 35MM |
| Generic Name | IMPLANT- SPINAL PROCESS FIXATION PLATE |
| Product Code | PEK |
| Date Received | 2014-01-08 |
| Catalog Number | 48590035 |
| Lot Number | B34436 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-01-08 |