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

Catalog Number	25740018570
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
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 reported 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 posterior fixation spinal surgery at l3/s2 due to some unspecified reasons.Post-op, screw on the right side s1 had ruptured the inner side.Patient underwent revision surgery as a result of this event.In which, direction of screw has been changed and reinserted again.No further patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Radiographic image review result: post-op x-ray for l2 - pelvis fixation are provided.Ap lateral images are provided.Interbody grafts are present at l2-3/3-4/4-5.By report there were 2 broken screws.It is difficult to see these on the provided images.Therefore, no further conclusion can be made and this complaint is considered closed unless further information is received to justify additional investigation.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: 9488229
• Report Number: 1030489-2019-01438
• Device Sequence Number: 13799086
• Product Code: NKB
• UDI-Device Identifier: 00643169414907
• UDI-Public: 00643169414907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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: 25740018570
• Device Lot Number: CA18F068
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 03/05/2020
• 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: 49 YR