MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-17 for VIRAGE SCREW, UNKNOWN manufactured by Zimmer Biomet Spine Inc..
[187427994]
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 3012447612-2020-00151 to 3012447612-2020-00156.
Patient Sequence No: 1, Text Type: N, H10
[187427995]
It was reported that a patient underwent a revision surgery to remove screws that were found to have backed out postoperatively after the patient reported pain. The surgeon removed the construct from c2-c7 without replacing the hardware. It was reported that the patient was old and her bones were not able to hold the screws. The surgeon stated that there was no fusion present at the time of the revision. The patient is reported to be wearing a neck brace but no further patient impacts were provided. This is report one of six for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2020-00151 |
| MDR Report Key | 9845305 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-17 |
| 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 | VIRAGE SCREW, UNKNOWN |
| Generic Name | VIRAGE OCT SPINAL FIXATION SYSTEM |
| Product Code | KWP |
| Date Received | 2020-03-17 |
| Model Number | NA |
| Catalog Number | NI |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-03-17 |