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 2017-12-11 for DYNESYS CORD N/A UNKNOWN manufactured by Zimmer Gmbh.
[94354001]
The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation. As no lot number was provided, the device history records could not be reviewed. Additional information has been requested and is currently not available. 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
[94354002]
It is reported that a patient was implanted with a dynesys cord (catalog and lot number unknown) on an unknown date. Patient returned to surgeon with recurrent pain on left side of the lumbar region. A scan showed that the spacer was not aligning properly with the dto implant and a fracture of the cord was assumed. As the disc of the treated level was regenerated and the lower level was fused the surgeon decided to remove the screws and connections. During the explantation (date u unknown), it could be clearly see that the cord indeed was broken at the cord-rod interface.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2017-01720 |
| MDR Report Key | 7103618 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-12-11 |
| Date of Report | 2018-03-07 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2018-02-14 |
| Date Added to Maude | 2017-12-11 |
| 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 CORD |
| Generic Name | NA |
| Product Code | NQP |
| Date Received | 2017-12-11 |
| Returned To Mfg | 2018-01-03 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-12-11 |