MAUDE Adverse Event Report: ALPHATEC SPINE INC PEDICLE PROBE, LENKE STRAIGHT (STAINLESS STEEL); HXB

Model Number	22SPT09
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned for evaluation nor has the identifying lot number been provided.Multiple attempts to obtain additional information have been unsuccessful.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
While the surgeon was inserting the probe into the pedicle, the instrument snapped and got stuck in the pedicle.

• Brand Name: PEDICLE PROBE, LENKE STRAIGHT (STAINLESS STEEL)
• Common Device Name: HXB
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6228675
• Report Number: 2027467-2016-00111
• Device Sequence Number: 13621589
• Product Code: HXB
• UDI-Device Identifier: 00840967190105
• UDI-Public: 00840967190105
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2016

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: Physician
• Device Model Number: 22SPT09
• Device Catalogue Number: 22SPT09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 01/06/2017
• 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