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

Model Number	71540-15
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is not possible at this time.The implants have not been returned nor has the identifying lot number(s) been provided.Upon the receipt of additional information and/or the suspect implants a follow report will be submitted.No other information or correspondence has been provided.
Event or Problem Description
Alphatec legal received a product liability claim on april 23, 2020.The claim alleges that two year post-op images revealed the bottom two screws has snapped and the c7 vertebrae was floating around in the patients neck.The patient initially underwent surgery on (b)(6) 2016 following a crush injury to his c4, c5, c6 and c7.The alphatec trestle luxe plating system was utilized during the anterior fusion.3, 6 and 12 month post-op visits did not display any concern.On (b)(6) 2019 during a 2 years post-op visit, x-rays appeared to show that the bottom 2 had snapped.Revision surgery was conducted on (b)(6) 2019 in which additional hardware was installed at the c4 thru t2.

• 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
• MDR Report Key: 10074444
• Report Number: 2027467-2020-00025
• Device Sequence Number: 2848849
• Product Code: KWQ
• UDI-Device Identifier: 00844856067905
• UDI-Public: (01)00844856067905
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71540-15
• Device Catalogue Number: 71540-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/20/2020
• 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: Hospitalization
• Patient Age: 48 YR