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 2018-06-19 for DYNESYS REVISION SCREW + SET SCREW, 7.2X40 N/A 01.03772.040 manufactured by Zimmer Gmbh.
[111431972]
The manufacturer did not receive the device for investigation. 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. The actual device reported in section d is not marketed in usa, but devices with similar characteristics (i. E. Dyn pedicle set scr 7. 2x40, ref:01. 03717. 240, k043565) are marketed in usa, and therefore this report was filed. 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
[111431973]
It was reported that during surgery the blocker threading couldn't be assembling with screw. The surgery was completed with another screw with a surgery delay of 60 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00629 |
| MDR Report Key | 7612779 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-06-19 |
| Date of Report | 2018-11-22 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-11-20 |
| Device Manufacturer Date | 2015-10-13 |
| Date Added to Maude | 2018-06-19 |
| 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 REVISION SCREW + SET SCREW, 7.2X40 |
| Generic Name | N/A |
| Product Code | NQP |
| Date Received | 2018-06-19 |
| Returned To Mfg | 2018-06-27 |
| Model Number | N/A |
| Catalog Number | 01.03772.040 |
| Lot Number | 2832106 |
| ID Number | 00889024464018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-06-19 |