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

Catalog Number	876-815
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Three lots of the suspect device was identified, however it is unknown which one is the complaint product.The lots that were used lot h5211776, qty 1; lot h5211614, qty 2; lot h5194980, qty 1.Pseudoarthrosis); 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 patient was pre-operative diagnosed with cervical spondylosis due to which the patient underwent anterior cervical spine surgery in which the plate and screws were implanted.Post-operative, one of the screw(s) implanted were reported to be fractured.The patient complained of discomfort and a hoarse voice as a result of this event.Patient has not yet achieved complete fusion.
Additional Manufacturer Narrative
Additional information: x rays image review: post op xrays from reported c3-4 acdf show a fractured screw in the c3 vertebral body.A peek interbody graft is used, unable to determine fusion status in the provided image.The screw does not appear bulged out.Suspect hoarseness is a result of the initial surgery.A good faith effort will be made to obtain the applicable information relevant to the report.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: 6688811
• Report Number: 1030489-2017-01678
• Device Sequence Number: 45834
• Product Code: KWP
• UDI-Device Identifier: 00673978955100
• UDI-Public: 00673978955100
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K970806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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: 876-815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 08/07/2017
• 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
• Patient Age: 49 YR
• Patient Weight: 66