MAUDE Adverse Event Report: ORTHOFIX SRL GUIDED GROWTH PLATE SYSTEM; SCREW, FIXATION, BONE

Model Number 1

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2023

Event Type  malfunction  

Event Description

The proximal screw would not come out and started stripping.The stripped screw extractor was used.The screw broke at the threads.The head and portion of screw was removed.

• Brand Name: GUIDED GROWTH PLATE SYSTEM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ORTHOFIX SRL; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 16822835
• MDR Text Key: 314087287
• Report Number: 16822835
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1
• Device Catalogue Number: T80132
• Device Lot Number: 33 04 16MAR 2022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4015 DA
• Patient Sex: Female
• Patient Weight: 59 KG