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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following products were used in the surgery: (product id: 3120517, qty: 3) (product id: 3120318, qty: 1) and (product id: 3125517, qty : 2).Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with non union and underwent anterior cervical discectomy and fusion (acdf) surgery at c4-7 levels.Post-operatively, a screw was broken in the body of c7.As a result, the broken portion of the screw was captured and removed from the c7 vertebral body.The products came in contact with the patient.No fragment of the screw remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Post-op x-rays of c4-c7 acdf show a backed out screw at c7.Solid fusion is apparent at c5-6, less so at c6-7 peek interbody grafts were used.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis results: the screw has broken 10mm from the tip.Both sections of the screw have been returned.A microscopic review of the fracture shows the area of crack propagation along with fatigue lines and a sheer lip.These factors are in line with one another and are consistent with cyclic fatigue leading to a material overload.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: 8109428
• Report Number: 1030489-2018-01566
• Device Sequence Number: 13886315
• Product Code: KWP
• UDI-Device Identifier: 00613994241160
• UDI-Public: 00613994241160
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2019

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: 05/22/2019
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 06/26/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 12/24/2018; 07/24/2019
• 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 Weight: 61