MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-10 for DYNESYSTL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35 N/A 01.03956.035 manufactured by Zimmer Gmbh.
[116754555]
(b)(4). Additional concomitant medical products: item # 0103711200 item name dynesys lis, stabilizing lot / # 2751522; item # 0103810006 item name dynesys tl, set screw lot # 2699345; item # 0103810006 item name dynesys tl, set screw lot / # 2699345; item # 0103956035 item name dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35 lot # unk; item number lookup item # 0103957250 item name dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35 lot 2701342. The manufacturer received x-rays and other source documents for review. The manufacturer did not receive the device for investigation. The device history records were reviewed and found to be conforming. 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
[116754556]
It was reported that a patient was initially implanted with dynesys implants and underwent second revision due to over correction approximately five years post implantation. The surgeon confirms, that no hardware was removed during second revision, but additional screws were placed. Note: the dynesys products remain implanted. Hence, no explantation date is captured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00793 |
| MDR Report Key | 7772571 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-10 |
| Date of Report | 2018-11-22 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-11-19 |
| Device Manufacturer Date | 2013-02-15 |
| Date Added to Maude | 2018-08-10 |
| 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 | DYNESYSTL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35 |
| Generic Name | DYNESYS TOP-LOADING SPINAL SYSTEM |
| Product Code | NQP |
| Date Received | 2018-08-10 |
| Model Number | N/A |
| Catalog Number | 01.03956.035 |
| Lot Number | 2963466 |
| Device Expiration Date | 2018-03-31 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-08-10 |