MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-02-06 for DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40 N/A 01.03956.040 manufactured by Zimmer Gmbh.
[99073134]
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. As no lot number was provided, the device history records could not be reviewed. 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 cmp(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[99073135]
It was reported that the patient had a revision procedure two years and four months post-implantation due to overcompensation. Attempts to obtain additional information have been made; however, no more is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00229 |
| MDR Report Key | 7243331 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-06 |
| Date of Report | 2018-08-06 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 2016-01-05 |
| Date Added to Maude | 2018-02-06 |
| 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 TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40 |
| Generic Name | DYNESYS TOP-LOADING SPINAL SYSTEM |
| Product Code | NQP |
| Date Received | 2018-02-06 |
| Returned To Mfg | 2018-05-02 |
| Model Number | N/A |
| Catalog Number | 01.03956.040 |
| Lot Number | 2842193 |
| ID Number | 00889024481619 |
| 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 | 2018-02-06 |