MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for SEQUOIA OPEN CLOSURE, 5.5M, TOP TI 3301-1 manufactured by Zimmer Biomet Spine Inc..
[186110661]
Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Reference reports 3012447612-2020-00189 to 3012447612-2020-00191.
Patient Sequence No: 1, Text Type: N, H10
[186110662]
It was reported that during the procedure the threads of three closure tops were damaged during the final torquing step. There was a greater than 30 minute delay while they were being replaced without reported patient harm. This is report three of three for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2020-00191 |
| MDR Report Key | 9876258 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-15 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-24 |
| 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. ASHLEY MCPHERSON |
| Manufacturer Street | 10225 WESTMOOR DR. NA |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | ZIMMER BIOMET SPINE INC. |
| Manufacturer Street | 10225 WESTMOOR DR. NA |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEQUOIA OPEN CLOSURE, 5.5M, TOP TI |
| Generic Name | SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM |
| Product Code | NKB |
| Date Received | 2020-03-24 |
| Model Number | NA |
| Catalog Number | 3301-1 |
| Lot Number | AAS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SPINE INC. |
| Manufacturer Address | 10225 WESTMOOR DR. WESTMINSTER CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-24 |