MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW (5.0 MM X 30 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number 07.01708.012

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/18/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that during the procedure the screw fractured while being implanted.The shaft of the screw was not able to be retrieved and was retained by the patient.There were no additional patient impacts reported, the patient was reported to be fine and recovering postoperatively.

Manufacturer Narrative

Information erroneously entered into h5 and h3: there are no changes from the initial report.The complaint is confirmed for one (1) of one (1) virage screw (pn 07.01708.012) for the reported failure of fractured.The severity of this event is 3 (rmf-sp0008-22).Product evaluation: the products were not returned, however, photos/x-rays were provided.The photos provided confirm the complaint that the screw has fractured off and the shaft remains implanted in the patient.The complaint is confirmed.Dhr review: the lot numbers were not provided, so the dhrs are unable to be reviewed cause: the products were not returned so an evaluation is unable to be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.Complaint history: review of complaint history for the 12 months prior to the notification date to the (b)(6) 2020 identified 0 other complaint(s) for this device for the same or a similar issue.Past actions: no actions (capa/scar/ie/hhe/hhed/holds/recalls) are associated with these part number 07.01708.012 or any of its associated lots.Device use and compatibility: this device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.Conclusion: no actions are required.

Event Description

It was reported that during the procedure the screw fractured while being implanted.The shaft of the screw was not able to be retrieved and was retained by the patient.There were no additional patient impacts reported, the patient was reported to be fine and recovering postoperatively.

• Brand Name: POLYAXIAL SCREW (5.0 MM X 30 MM L)
• Type of Device: VIRAGE OCT SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10402305
• MDR Text Key: 202741431
• Report Number: 3012447612-2020-00445
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: K133556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.01708.012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other