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

Model Number	403185
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The retained pin fragment was not removed from the patient.The other fragment was discarded and not returned.No further investigation was possible on this part, but the device history records and samples from the same lot of pins were reviewed.No issues or discrepancies were found in the manufacturing records or samples from the lot.(p/n: 403185, l/n: 16012101 dm).Note: the navigation system name is orthalign plus.The pin part number 403185 is part of the reusable instrument set in the system.
Event or Problem Description
At the completion of a navigated tha case, a fixation pin broke during removal.The pin broke near the surface of the iliac crest, and separated into 2 fragments.The proximal fragment was removed and discarded.The distal section of the pin was retained in the patient's iliac wing.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: COMPUTER ASSISTED SURGERY SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia, ste 500; aliso viejo CA 92656
• MDR Report Key: 6004057
• Report Number: 3007521480-2016-00004
• Device Sequence Number: 794336
• Product Code: OLO
• UDI-Device Identifier: 00858704006725
• UDI-Public: 00858704006725
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 403185
• Device Catalogue Number: 403185
• Device Lot Number: 16012101DM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2016
• Initial Report FDA Received Date: 10/06/2016
• 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: 65 YR
• Patient Weight: 66