MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	3120516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that on an unknown date the patient underwent three level anterior cervical discectomy fusion.Post-op, the surgeon found three broken screw in cervical vertebrae of the patient as seen on radiograph film.On (b)(6) 2017 the patient revision surgery as a result of the event.The broken screws were replaced with different products and level of treatment was extended.Tips of the three screws remain in patient cervical vertebrae.The patient had not achieved solid fusion.
Additional Manufacturer Narrative
Product analysis: a microscopic review of the fracture surface of the screw returned identified ratchet marks and progressive convex striations, which are indicative of fatigue to mechanical failure of the screw.There was no material defect noted near the area of crack propagation.The minor diameter was checked and the part met print specifications.The above observations are consistent with cyclic fatigue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6878263
• Report Number: 1030489-2017-02080
• Device Sequence Number: 1183387
• Product Code: KWQ
• UDI-Device Identifier: 00613994241153
• UDI-Public: 00613994241153
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K063100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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 Catalogue Number: 3120516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 06/21/2018
• 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: Required Intervention
• Patient Age: 65 YR