MAUDE Adverse Event Report: BIOPRO, INC GO-EZ SCREW; CANNULATED BONE SCREWS

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Biopro became aware of 2 go-ez screws which failed at some point after implantation.At this time we have not been able to obtain item or lot numbers to be able to conduct a review of the manufacturing records.At this time the screws have not been removed from the patient so an investigation cannot be conducted.As more information becomes available this mdr will be updated.

• Brand Name: GO-EZ SCREW
• Type of Device: CANNULATED BONE SCREWS
• Manufacturer (Section D): BIOPRO, INC; 2929 lapeer rd; port huron MI 48060
• Manufacturer (Section G): BIOPRO, INC; 2929 lapeer rd; port huron MI 48060
• Manufacturer Contact: kimberly light ; 2929 lapeer rd; port huron, MI 48060 ; 8109827777
• MDR Report Key: 16025139
• MDR Text Key: 305922178
• Report Number: 1832656-2022-00001
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K081149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female