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
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: a visual and a microscopic review of all parts returned indicated that the two bigger screws and two of the set screws had heavy witness marks from the rod moving in between the two components.From witness marks on the rods, it appears that these two screws were located on the end of the construct.One of the bone screws has a witness mark on the head of the screw indicating that the rod came in contact with the head.This is consistent with the angulation of the rod and bone screw head.There are also witness marks on the shaft of the bone screw from where the bone screw head was sitting fully angulated.The other items returned did not appear to have issues.It appears the steep angulation between the two screws and rods could have led to the set screw loosening.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent anterior vertebral body replacement surgery and posterior fixation at t4-s2ai due to vertebral body collapse at l4.On an unknown date, post op, set screw on the caudal side totally backed out from the screw head at s1/s2ai.Since on one side, the direction of the screw head at s1 and the screw head at s2ai were different, it was difficult to have back out issue, but all the four set screws still backed out.The patient also had pain in the lower back due to set screw backing out.Hence, the patient underwent a revision surgery, in which screw replacement and fusion for extending the rod was performed.

• Brand Name: CD HORIZON BALLAST SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8606820
• Report Number: 1030489-2019-00537
• Device Sequence Number: 11307708
• Product Code: NKB
• UDI-Device Identifier: 00643169414914
• UDI-Public: 00643169414914
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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 Expiration Date: 06/21/2024
• Device Catalogue Number: 25740018580
• Device Lot Number: CA16E058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SET SCREW, ROD
• Outcome Attributed to Adverse Event: Required Intervention