MAUDE Adverse Event Report: ALPHATEC SPINE, INC. T25 SELF RETAINING DRIVER (STAINLESS STEEL); HXX

Model Number	87013
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned for evaluation.Upon the receipt of additional information and/or the return of the illico tap a follow-up report will be submitted.
Event or Problem Description
While inserting the screw into the pedicle, the tip of the t25 driver broke off in the head of the screw.The surgery was completed successfully.Everything was removed from the patient and the patient was not harmed in the process.

• Brand Name: T25 SELF RETAINING DRIVER (STAINLESS STEEL)
• Common Device Name: HXX
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 7906614
• Report Number: 2027467-2018-00070
• Device Sequence Number: 941154
• Product Code: HXX
• UDI-Device Identifier: 00844856069589
• UDI-Public: (01)00844856069589(10)687002S2
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/10/2018

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: 87013
• Device Catalogue Number: 87013
• Device Lot Number: 687002S2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 09/25/2018
• 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: 68 YR