MAUDE Adverse Event Report: ALPHATEC SPINE INC TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM; HXX

Model Number	71731-02
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection of the returned inner shaft confirmed that the distal threaded tip had fractured and separated from the instrument.The detached section which remains implanted within the c5 screw is approximately.125" in-length.In addition to the inner shaft, there was also a total of three separate hexalobe screw removal tools used in conjunction which also broke during the case.It is unknown which outer shaft fragment also remains within the screw.713-0001, lot 812100r1 mfg'd oct-2019, 71731-01, lot 6630201 mfg'd nov-2017, 71731-01, lot 8063701 mfg'd may-2012.All the remaining distal tips of all three screw removal tools appear to have been bent/twisted in a clockwise direction which is associated with tightening.These instrument are intended to be used for screw removal.Additionally, the detached sections of all the instruments utilized in the case are manufactured out of 465ss (stainless steel) and certified to astm a564-13.
Event or Problem Description
During an acdf case of the c4-c7, the surgeon was inserting screws using the screw remover tool and the distal tips fractured and broke.The tips of both the outer and inner shafts remain within the screw head positioned within the right c5 vertebrae.

• Brand Name: TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM
• Common Device Name: HXX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 9835069
• Report Number: 2027467-2020-00018
• Device Sequence Number: 1551445
• Product Code: HXX
• UDI-Device Identifier: 00840967192673
• UDI-Public: (01)00840967192673(10)7538301
• Combination Product (Y/N): N
• 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): 02/18/2020

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: Health Professional
• Device Model Number: 71731-02
• Device Catalogue Number: 71731-02
• Device Lot Number: 7528301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/16/2020
• 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: 62 YR