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

Catalog Number	3120515
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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 cervical nerve compression and underwent anterior decompression surgery of the cervical spine.During surgery, the set screws slipped.Hence, they had to be explanted.The procedure was completed successfully with a new product.No adverse event was associated with the screws.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the screw was returned showing signs of use, hex showing deformation and the threads at the o.D.Of the screw having had the anodization rubbed off from installation.The o.D.Of the screw was checked and meets the print specification.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: 7636635
• Report Number: 1030489-2018-00899
• Device Sequence Number: 1529644
• Product Code: KWP
• UDI-Device Identifier: 00613994241146
• UDI-Public: 00613994241146
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2018

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 Catalogue Number: 3120515
• Device Lot Number: H5415309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018; 09/05/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/06/2018; 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1