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

Catalog Number	25840018590
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent open lumbar fusion at l2-pelvis.On an unknown date, post-op, set screw dislodged from the pedicle screw.Hence, a revision surgery was performed, in which the loose screw was removed and was replaced with bigger screw.No other patient complications were reported.
Additional Manufacturer Narrative
X-ray review results: post-op x-rays for multilevel thoracic to pelvic fixation were provided.Interbody grafts are present at l5-s1, l4-l5 and l3-l4 appear to be previous artificial disc replacements.One of the set screws at the sacrum is out of the screw head.Fusion status is unknown.If information is provided in the future, a supplemental report will be issued.

• 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: 9470709
• Report Number: 1030489-2019-01425
• Device Sequence Number: 16236680
• Product Code: NKB
• UDI-Device Identifier: 00643169413276
• UDI-Public: 00643169413276
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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 Catalogue Number: 25840018590
• Device Lot Number: CA16K117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/14/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 83