MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE SCREW, UNKNOWN TYPE OR SIZE; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Device Problem Fracture (1260)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

510k number: unknown, but could be similar to k061441.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 a revision surgery was performed to address a polaris construct the broke after the patient fell.No further information has been provided.

Event Description

It was reported that a revision surgery was performed to address a polaris construct the broke after the patient fell.No further information has been provided.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and photos were not provided, so device evaluation could not be performed.Potential cause root cause was unable to be determined.This event could possibly be attributed to the traumatic event experienced by the patient.Dhr review s lot number not provided, so dhr review could not be performed.Device use this device is used for treatment.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.

• Brand Name: PEDICLE SCREW, UNKNOWN TYPE OR SIZE
• Type of Device: EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 12388654
• MDR Text Key: 268902548
• Report Number: 3012447612-2021-00338
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: SEE-H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention