MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-28 for 6.5 X 50MM MULTIAXIAL SCREW 2000-2450 manufactured by Zimmer Biomet Spine Inc..
[181482334]
Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. 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 3012447612-2020-00140 to 3012447612-2020-00149.
Patient Sequence No: 1, Text Type: N, H10
[181482335]
It was reported that during a spondylolisthesis correction procedure, the tulip heads shifted allowing the rods to bend towards the vertebrae rather than the vertebrae shifting to the location of the rod. The correction of the deformity was ineffective, the implants were tightened and left in place to complete the case. There were no reported additional patient impacts and no revision is scheduled at this time. This is report two of ten.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2020-00141 |
| MDR Report Key | 9770826 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-28 |
| 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 | 6.5 X 50MM MULTIAXIAL SCREW |
| Generic Name | EBI 5.5 HELICAL FLANGE SPINAL SYSTEM |
| Product Code | MNH |
| Date Received | 2020-02-28 |
| Model Number | NA |
| Catalog Number | 2000-2450 |
| Lot Number | NI |
| 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 | 2020-02-28 |