MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG DIVERGENCE¿ ANTERIOR CERVICAL FUSION SYSTEM

Catalog Number G6626748

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Neck Pain (2433)

Event Date 02/16/2018

Event Type  Injury  

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient was presented with hernia in c6-7, post-op, c6-c7 collapsed.Patient underwent corpectomy and fixation with explantation surgery to treat neck pain and injury.

• Brand Name: DIVERGENCE¿ ANTERIOR CERVICAL FUSION SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7359053
• MDR Text Key: 103087543
• Report Number: 1030489-2018-00428
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 00643169337350
• UDI-Public: 00643169337350
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K141599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: G6626748
• Device Lot Number: H5378650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 80