MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS; COMPUTER ASSISTED SURGERY SYSTEM

Model Number	403349
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An orthalign plus system was used for navigation in a total hip arthroplasty procedure.The surgeon completed the initial femoral registration for the change in leg length measurement.The surgeon then completed the registrations and navigation for the acetabular shell placement.During the second femoral registration to measure the change from initial position for leg length measurement, the surgeon discovered that the registration tack had loosened from the bone.The surgeon removed the tack and discarded it.He was not able to complete the leg length measurement.No specific issue was identified with the device that may have caused the issue.The surgeon noted that the patient had soft bone, and this may have contributed.Since the part was not returned, we were not able to inspect it.We reviewed the manufacturing and inspection records for the lot and did not discover any anomalies or issues related to the event.Device not returned.
Event or Problem Description
A surgeon reported that he completed a hipalign case the prior day."everything was going smoothly until i went to take my final measurement and realized that my femoral tack had come loose." the surgeon removed the tack, but was unable to get a final measurement for the change in leg length.It wasn't immediately clear to the surgeon what had caused the tack to come loose.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: COMPUTER ASSISTED SURGERY SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia, suite 500; aliso viejo CA 92656
• MDR Report Key: 6685425
• Report Number: 3007521480-2017-00004
• Device Sequence Number: 1039698
• Product Code: OLO
• UDI-Device Identifier: 00851977007666
• UDI-Public: 00851977007666
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 403349
• Device Catalogue Number: 403349
• Device Lot Number: 17041401BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 07/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Weight: 68