MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON BALLAST SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 25740018580

Device Problems No Apparent Adverse Event (3189); Migration (4003)

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

Event Date 01/29/2020

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

Event Description

Intra-op, the set screw had come off from the ballast screw placed on the caudal side.Hence the ballast screw is explanted.

Manufacturer Narrative

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

Event Description

As per the update received, there is no issue with the reported screw.

• Brand Name: CD HORIZON BALLAST SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 9756042
• MDR Text Key: 181347059
• Report Number: 1030489-2020-00222
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169414914
• UDI-Public: 00643169414914
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153442
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25740018580
• Device Lot Number: CA18H098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR