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

Catalog Number	3120513
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Neck Pain (2433)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient underwent anterior discectomy and fusion at c3-c7.Post-op, the levels at c4-5 and c5-6 collapsed and the implanted screws at c3-c4 loosened and came out of the plate even though the locking mechanism was locked.One of the 13mm screws completely came out of the plate and was floating free in the patient due to which patient suffered with neck pain.The patient underwent revision surgery (anterior cervical discectomy and fusion) to remove the implants.
Additional Manufacturer Narrative
Product analysis results: visual functional the plate was returned with all the locks in the locked position except for one.There are witness marks on all the locks where it appears that the screws were removed with the locks in place.Depending on the force and the angle of the screw in relation to the locking mechanism it is possible for the screw to be pushed through the locking mechanism.From the witness marks, it would appear that at one point the locks were in place and on the screws.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
• MDR Report Key: 7074069
• Report Number: 1030489-2017-02430
• Device Sequence Number: 16462565
• Product Code: KWP
• UDI-Device Identifier: 00613994239679
• UDI-Public: 00613994239679
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: 3120513
• Device Lot Number: H5345373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 05/09/2018
• 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: Other; Required Intervention