MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-01-16 for ZIP MIS INTERSPINOUS FUSION SYSTEM 001-14-S-ZIP 001-014-S-ZIP manufactured by Aurora Spine.
[5316022]
During an ultra zip case, while compressing the zip implant, the legs of zip both bent and broke and in doing so also the pt's spinous process. The surgeon did not pursue trying to find another implant. The pt was eventually fused in-situ and the surgeon may eventually decided to go back and stabilize with other instrumentation if needed.
Patient Sequence No: 1, Text Type: D, B5
[12973737]
The distributor contact explained that during the surgery, the surgeon did not use the large compressor per the surgical technique guide provided. The surgeon kept the ligament, but broke the zip device first and then the spinous process. A request for follow up was sent to the surgeon. The surgeon responded that inserting the zip implant was smooth, but then he said he does not want to talk about this right now. The surgeon removed the zip implant and closed the pt. A conference call is set up to discuss this further.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010326971-2014-00002 |
| MDR Report Key | 4447084 |
| Report Source | 07 |
| Date Received | 2015-01-16 |
| Date of Report | 2015-01-13 |
| Date of Event | 2014-12-15 |
| Date Mfgr Received | 2014-12-15 |
| Date Added to Maude | 2015-01-26 |
| 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 | MIKE THOMPSON, DIR, RA/QA |
| Manufacturer Street | 1920 PALOMAR POINT WAY |
| Manufacturer City | CARLSBAD CA 920080000 |
| Manufacturer Country | US |
| Manufacturer Postal | 920080000 |
| Manufacturer Phone | 6764242004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIP MIS INTERSPINOUS FUSION SYSTEM |
| Generic Name | INTERSPINOUS FUSION DEVICE |
| Product Code | PEK |
| Date Received | 2015-01-16 |
| Returned To Mfg | 2014-12-17 |
| Model Number | 001-14-S-ZIP |
| Catalog Number | 001-014-S-ZIP |
| Lot Number | 130049-4 |
| Device Expiration Date | 2016-03-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AURORA SPINE |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-16 |