MAUDE Adverse Event Report: ALPHATEC SPINE, INC TRESTLE LUXE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	71440-12
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The implant has not been removed from the patient 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 trestle luxe c7 bone screw backed out.
Additional Manufacturer Narrative
Corrected data: d.6a.(b)(6) 2017.H6: medical device code: 2923 component code: 568 type of investigation: 4144 investigation findings: 3231.

• Brand Name: TRESTLE LUXE
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12321697
• Report Number: 2027467-2021-00057
• Device Sequence Number: 4424998
• Product Code: KWQ
• UDI-Device Identifier: 00844856067752
• UDI-Public: 00844856067752
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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?: Yes
• Operator of Device: No Information
• Device Model Number: 71440-12
• Device Catalogue Number: 71440-12
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 10/22/2021
• 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: 60 YR