MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-04 for DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35 N/A 01.03956.035 manufactured by Zimmer Gmbh.
[113160027]
Additional concomitant medical products: dynesys lis, stabilizing cord, 200, catalog no. : 0103711200 ; lot no# unknown; dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35, catalog no. : 0103956035 ; lot no# unknown; dynesys set screw spine impl win gen, catalog no. : unknown, lot no. : unknown; dynesys set screw spine impl win gen, catalog no: unknown, lot no. : unknown; dynesys staples spine impl win gen, catalog no. : 187701010, lot no. : unknown. Therapy date: (b)(6) 2014. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. 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
[113160028]
Patient was implanted and underwent revision surgery due to overcorrection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00678 |
| MDR Report Key | 7662107 |
| Date Received | 2018-07-04 |
| Date of Report | 2018-11-22 |
| Date of Event | 2014-08-27 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-07-04 |
| 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 | 0 |
| Brand Name | DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35 |
| Generic Name | DYNESYS TOP-LOADING SPINAL SYSTEM |
| Product Code | NQP |
| Date Received | 2018-07-04 |
| Model Number | N/A |
| Catalog Number | 01.03956.035 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| 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 | 2018-07-04 |