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

Catalog Number	25740019590
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
It was reported that the patient was pre-operatively diagnosed with lumbar canal stenosis and underwent sacral-iliac fusion at s2 and extending towards caudal side.Post-op, the set screw of s2ai screw backed out.Pain occurred due to the loosening of s1 screw.A revision surgery was performed on (b)(6) 2018 to replace the screw.
Additional Manufacturer Narrative
Product analysis: visual inspection did not reveal any non-conformance that could contribute to the screw backing out.Functional test with sample break off screw confirmed the screw would thread into the head of the bone screw.Optical examination confirmed witness marks on the head of the screw that indicates the rod came in contact with the saddle and damage to the crown of the screw.Microscopic examination of the wire hole confirmed part of the wire was still embedded.The end of the wire appeared to be damaged and broken.Dimensional inspection confirmed conformance to print specification.Root cause of the screw backing out is undetermined.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: 8098501
• Report Number: 1030489-2018-01521
• Device Sequence Number: 1721788
• Product Code: NKB
• UDI-Device Identifier: 00643169415010
• UDI-Public: 00643169415010
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 07/01/2024
• Device Catalogue Number: 25740019590
• Device Lot Number: CA16E089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 11/22/2018
• Supplement Report FDA Received Date: 04/11/2019
• 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