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 Deformation (2976)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: medical equipment company technician/representative although it is unknown if the device contributed to the reported event, we are filing this report for notification purposes.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 or Problem Description
Pre-operative diagnosis: proximal junctional kyphosis procedure: implant replacement and debridement levels implanted: s2 it was reported that on an unknown date, post-op, after fusion was performed on t10/s2ai due to adult spine deformity, infection occurred (corynebacteria).At the time of debridement, it was confirmed that the set screw backed out.This time the replacement of the reported product was also performed along with the replacement of the rod.Revision surgery was performed as a result of the event.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the screw has been used and the screw's lower pivot cap has been damaged.The pivot cap of the screw appears to have been worn down from repetitive contact from a rod that was placed in the saddle of the screw.This is consistent with repeated use or contact.The threads of the screw show no signs of being damaged during entry or removal.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: 7841134
• Report Number: 1030489-2018-01202
• Device Sequence Number: 16640847
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2018

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: 25740018570
• Device Lot Number: CA16E072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 12/24/2018
• 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: Other; Required Intervention