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

Catalog Number G6626525

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the patient underwent anterior cervical fusion at c4-c6.Intra-op, the cage was shaved by the screw.The screw was being inserted at c4-c5 from the cranial side to the caudal side.When using a straight driver, it was touching the jaw; so, the angled driver was used.But the angled driver was also touching the jaw, which caused the driver shaft to wobble.During insertion of the screw, the screw interfered with the cage; hence, a new cage was opened to complete the procedure.After replacing the cage, the doctor inserted the screw with pressing the driver shaft in order to avoid shaft wobbling.There was a delay of less than 60 minutes in overall procedure time as a result of this event.There were no patient symptoms or complications as a result of this event.

Manufacturer Narrative

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

• 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: 8467919
• MDR Text Key: 140499210
• Report Number: 1030489-2019-00357
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 00643169337558
• UDI-Public: 00643169337558
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G6626525
• Device Lot Number: H5500423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2019
• 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
• Patient Age: 56 YR