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

Catalog Number	3120215
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Weakness (2145)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
X-ray review results: post-op x-ray for c5-6 fusion.The superior screws are very low in the c5 vertebral body and at a flat trajectory.Unknown what type of interbody graft is present.There is a paucity of bone.The plate appears fractured below the c5 screw on ap view.Other: pain, cracking, popping, left upper extremity weakness.H6: product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported via a patient call that on (b)(6) 2019 during post-op clinic visit x-ray revealed that the implanted screw was loosened and had not been fused.The patient is suffering from pain, cracking, popping, left upper extremity weakness as a result of this event.Patient underwent physical therapy as well.On (b)(6) 2020 he was scheduled to have ct scans and mri but no new information has been received yet.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
As per patient, on (b)(6) 2020 the patient visited the doctor and his pa, they informed that the hardware from the images taken in july revealed that it was broken.The ct showed that some spot wielding occurred and an incomplete fusion.His only options are to wait for six months to see if more bone growth occurs, or a posterior neck fusion.He is going to wait for six months, post that the hardware removed.He does not want to take the risk of what bone growth or break in surgery.After that he would be a posterior fusion at that point.
Additional Manufacturer Narrative
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: 9652133
• Report Number: 1030489-2020-00117
• Device Sequence Number: 1690995
• Product Code: KWP
• UDI-Device Identifier: 00613994239921
• UDI-Public: 00613994239921
• Combination Product (Y/N): N
• PMA/510(K) Number: K063100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2020

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: 3120215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/03/2020; 02/13/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 01/31/2020; 03/12/2020
• 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