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 2018-04-19 for DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40 N/A 01.03956.040 manufactured by Zimmer Gmbh.
[105875933]
The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation. The device history records were reviewed and found to be conforming.. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[105875934]
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 | 0009613350-2018-00453 |
| MDR Report Key | 7442419 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-19 |
| Date of Report | 2018-08-06 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 2016-02-18 |
| Date Added to Maude | 2018-04-19 |
| 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 TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40 |
| Generic Name | DYNESYS TOP-LOADING SPINAL SYSTEM |
| Product Code | NQP |
| Date Received | 2018-04-19 |
| Returned To Mfg | 2018-05-20 |
| Model Number | N/A |
| Catalog Number | 01.03956.040 |
| Lot Number | 2844441 |
| 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 | 2018-04-19 |