MAUDE Adverse Event Report: ALPHATEC SPINE INC INVICTUS SPINAL FIXATION SYSTEM; HXB

Model Number	17001-01
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned nor has the identifying lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
The tip of the probe broke off inside the patients pedicle.The detached section was removed without issue.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: HXB
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 9519501
• Report Number: 2027467-2019-00061
• Device Sequence Number: 19560246
• Product Code: HXB
• UDI-Device Identifier: 00190376195643
• UDI-Public: (01)00190376195643
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/04/2019

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: 17001-01
• Device Catalogue Number: 1700-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/26/2019
• 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