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

Catalog Number	3120313
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); 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.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent c5/6 anterior cervical discectomy fusion.Post-op, patient had pain after the surgery.Allegedly, "patient feels that the screws sticking out of her neck as well as when she touches that area of her neck it throbs".

• 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: 7359029
• Report Number: 1030489-2018-00427
• Device Sequence Number: 11038692
• Product Code: KWP
• UDI-Device Identifier: 00613994239679
• UDI-Public: 00613994239679
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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: 3120313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/21/2018
• 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: Other