MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-05-02 for DYNESYS LIS, STABILIZING CORD, 200 N/A 01.03731.200 manufactured by Zimmer Gmbh.
[143828428]
This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states under 510(k) number k031511. The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation. The manufacturer did not receive x-rays, or other source documents for review. Device history record (dhr) was reviewed and no discrepancies were found. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet? S reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[143828429]
It was reported that during surgery the outer layer of a cord was torn a bit. Therefore the torn cord was removed and a new one was applied. The surgery was delayed by 45 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2019-00278 |
| MDR Report Key | 8573379 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-02 |
| Date of Report | 2019-07-26 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-07-18 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2019-05-02 |
| 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, 200 |
| Generic Name | N/A |
| Product Code | NQP |
| Date Received | 2019-05-02 |
| Model Number | N/A |
| Catalog Number | 01.03731.200 |
| Lot Number | 2854896 |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-05-02 |