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

Model Number 36-1605

Device Problems Positioning Failure (1158); Leak/Splash (1354)

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

Event Date 09/25/2020

Event Type  malfunction  

Event 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
• Type of Device: TALL ADAPTER
• Manufacturer (Section D): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: yolanda thompson ; 3451 plano parkway; lewisville, TX 75056 ; 2149372291
• MDR Report Key: 10800728
• MDR Text Key: 239407517
• Report Number: 2183449-2020-00008
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 18257200133543
• UDI-Public: 18257200133543
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 36-1605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2020
• 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 Age: 65 YR