MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SOLERA VOYAGER SPINAL SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NAV6550005

Device Problem Break (1069)

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

Event Date 11/08/2019

Event Type  malfunction  

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.

Event Description

It was reported that the patient underwent hardware removal and re-insertion surgery due to non-union.Intra-op, while inserting the screw, tip of the driver broke off into the head of the screw.The surgeon removed the screw that had the broken portion stuck in it; and inserted a new screw.No patient complications were reported due to this event.

Manufacturer Narrative

Product analysis: visual and optical inspection revealed the tip of the driver has been broken off.Optical inspection revealed a very flat/smooth fracture with circular material flow.This type of damage is consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9528596
• MDR Text Key: 184518049
• Report Number: 1030489-2019-01504
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00643169754522
• UDI-Public: 00643169754522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NAV6550005
• Device Lot Number: CA17G009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2019
• Initial Date FDA Received: 12/29/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR