MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-10-17 for DYNESYS SCREW SPINE N/A manufactured by Zimmer Gmbh.
[123941181]
Additional device information: unique identifier (udi) # n/a. Concomitant medical products and therapy date. Detail of product: item number: unknown; item name: dynesys cord spine impl win gen; lot # unknown. Item number: unknown; item name: dynesys spacer spine impl win gen; lot # unknown. As no lot number was provided, the device history records could not be reviewed. The manufacturer did not receive x-rays, or other source documents for review, neither the device has been received for investigation as the patient has not been revised. 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
[123941182]
It was reported that patient started to be monitored following pain due to torn out / migrated screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-01077 |
| MDR Report Key | 7973177 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-10-17 |
| Date of Report | 2019-02-25 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2018-10-17 |
| 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 SCREW SPINE |
| Generic Name | N/A |
| Product Code | NQP |
| Date Received | 2018-10-17 |
| Model Number | N/A |
| Catalog Number | DYNESYS SCREW SPINE |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| 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 | 2018-10-17 |