MAUDE Adverse Event Report: ALPHATEC SPINE INC ZODIAC LUMBAR SPINAL FIXATION SYSTEM; HXX

Model Number	92939
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records revealed the instrument was properly manufactured and released in accordance with design specifications.No irregularities have been identified.Visual inspection revealed that approximately 0.057" of the distal tip had fractured and separated from the device.The reminder of the hexalobe edges are slightly rolled over and deformed on one side.The other side is crisp and defined as manufactured.This indicates the instrument failed due to excessive lateral bending/fatigue stress.Users should not expect to see this type of failure when used in a twisting motion as intended.
Event or Problem Description
The tip of the driver fractured and broke during use.

• Brand Name: ZODIAC LUMBAR SPINAL FIXATION SYSTEM
• Common Device Name: HXX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 9444697
• Report Number: 2027467-2019-00058
• Device Sequence Number: 502118
• Product Code: HXX
• UDI-Device Identifier: 00844856044357
• UDI-Public: (01)00844856044357(10)6818401
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2019

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: 92939
• Device Catalogue Number: 92939
• Device Lot Number: 6818401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/10/2019
• 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