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

Device Problem Material Deformation (2976)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

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 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.

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
• 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: 7841134
• MDR Text Key: 119019534
• Report Number: 1030489-2018-01202
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169414907
• UDI-Public: 00643169414907
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25740018570
• Device Lot Number: CA16E072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other; Required Intervention