MAUDE Adverse Event Report: ORTHOFIX INC. SKYHAWK; LATERAL INTERVERTEBRAL SPACER

Model Number	27-2438
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided, via medwatch form (b)(4), states that while implanting cage into the spinal space, the implant broke.All pieces were removed.No patient harm.Additional information received states that during a lateral interbody fusion (l2-l5) the implant got stuck and broke while it was going into the spinal space.All of the implant pieces were retrieved from the patient.This resulted in a delay in the case.

• Brand Name: SKYHAWK
• Common Device Name: LATERAL INTERVERTEBRAL SPACER
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 8167311
• Report Number: 2183449-2018-00036
• Device Sequence Number: 19197274
• Product Code: MAX
• UDI-Device Identifier: 18257200088539
• UDI-Public: 18257200088539
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 27-2438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR