MAUDE Adverse Event Report: ALPHATEC SPINE INC TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71003-051
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records revealed no manufacturing or processing related irregularities.The trestle luxe plate was found to be properly manufactured and released in accordance with design specifications.Root cause cannot be determined.The condition of the returned plate does not allow for a comprehensive evaluation.
Event or Problem Description
During revision surgery for an unrelated issue (patient accident & re-fractured upper levels) the surgeon noticed the sliding gold mechanism of the plate had been broken.

• Brand Name: TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 9588593
• Report Number: 2027467-2019-00066
• Device Sequence Number: 367276
• Product Code: KWQ
• UDI-Device Identifier: 00844856067103
• UDI-Public: (01)00844856067103(10)715609
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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: 71003-051
• Device Catalogue Number: 71003-051
• Device Lot Number: 715609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/14/2020
• 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: 60 YR