MAUDE Adverse Event Report: ORTHOFIX MEDICAL INC FIREBIRD NXG; SET SCREW

Model Number	36-2001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that patient had l3-s1 posterior lumbar interbody fusion (plif) surgery on (b)(6) 2020.In was found via x-rays during follow-up visit that two of the locking caps from s1 had become loose.A revision surgery was performed on (b)(6) 2020 to remove and replace the hardware at s1.

• Brand Name: FIREBIRD NXG
• Common Device Name: SET SCREW
• Manufacturer (Section D): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 10680951
• Report Number: 2183449-2020-00007
• Device Sequence Number: 14218133
• Product Code: NKB
• UDI-Device Identifier: 18257200084487
• UDI-Public: 18257200084487
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 36-2001
• Device Lot Number: O21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR