MAUDE Adverse Event Report: ORTHOFIX MEDICAL INC JANUS FENESTRATED SCREWS; TALL ADAPTER

Model Number	36-1605
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that during a case on (b)(6) 2020, the cement leaked out of the tall adapter and into the tulip head of the open body assembly.The surgeon was unable to seat the rod correctly.A revision surgery was performed on (b)(6) 2020 to remove the open body assembly and re-seat the rod.

• Brand Name: JANUS FENESTRATED SCREWS
• Common Device Name: TALL ADAPTER
• Manufacturer (Section D): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 10800728
• Report Number: 2183449-2020-00008
• Device Sequence Number: 2601674
• Product Code: NKB
• UDI-Device Identifier: 18257200133543
• UDI-Public: 18257200133543
• 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): 11/05/2020

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: Health Professional
• Device Model Number: 36-1605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR