MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-15 for DYNESYS LIS, STABILIZING CORD, 100 N/A 01.03711.100 manufactured by Zimmer Gmbh.
[102439176]
The manufacturer did not receive the device for investigation as it is still implanted. No surgical report or x-rays were provided for review. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. Additional information has been requested and is currently not available. As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. Zimmer's reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102439177]
It was reported that during a l4-s1 fusion surgery, the surgeon was not able to tighten the dynesys stabilizing cord. Nevertheless, the cord was used and remains implanted. The surgery was delayed for 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00359 |
| MDR Report Key | 7340627 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-15 |
| Date of Report | 2018-09-10 |
| Date of Event | 2017-11-15 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2016-11-15 |
| Date Added to Maude | 2018-03-15 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNESYS LIS, STABILIZING CORD, 100 |
| Generic Name | DYNESYS SPINAL SYSTEM |
| Product Code | NQP |
| Date Received | 2018-03-15 |
| Model Number | N/A |
| Catalog Number | 01.03711.100 |
| Lot Number | 2884765 |
| ID Number | 00889024482241 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-15 |