MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM

Catalog Number	3604012
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes to adverse event: other - unstable neck.Product was not 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 underwent posterior cervical fusion (pcf) from c3 to t2.Post-op, the lateral mass screws pulled out of c3, c4, and c5.This left the patient's neck unstable.The surgeon said that the patient did not fall and has been wearing a collar throughout post-op recovery.The patient will require revision surgery as a result of this event on a later date.
Additional Manufacturer Narrative
X-ray review results: post-op x-ray for c3-t2 (by report) fusion.There is a kyphotic deformity present in the cervical spine.All of the cervical screws have pulled out back with the c3 screw out of the bone entirely.The bottom level are not visualized.By report the cervical screws are 12 mm.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The revision surgery took place on (b)(6) 2020.The revision surgery went well, and the surgeon was able to anchor new screws for a stronger construct.We have not heard of any complications since the revision.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9754833
• Report Number: 1030489-2020-00215
• Device Sequence Number: 11229041
• Product Code: KWP
• UDI-Device Identifier: 00643169554627
• UDI-Public: 00643169554627
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K163375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 3604012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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; Required Intervention
• Patient Age: 56 YR