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

Catalog Number	25740018510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
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
Pre-operative diagnosis: stenosis, t10-pelvis with possible pso (polycystic ovary syndrome) levels implanted: s2 alar screw it was reported that intra-op, the surgeon implanted a screw.On removal of the screw the surgeon noticed that the pin was sticking out of the head of the screw.The screw was broken but no fragment remained in the patient.No patient complications were reported as a result.
Additional Manufacturer Narrative
Product analysis results: visual microscopic a visual review reveals that the assembly wire has been pushed back out of the wire slot.A microscopic review of the end of the wire and wire slot indicates that there is some deformation near the end of the wire indicating that it was once locked into place.The diameter of the wire appears to be the size called out on the print.There is damage to the neck of the screw and to the ring.It appears that the screw and the sub-assembly became locked together and pinched the wire causing it to be forced out of the wire slot while the screw was being turned clockwise with the internal torx or the head was turned counter clockwise.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: 8477608
• Report Number: 1030489-2019-00378
• Device Sequence Number: 13933187
• Product Code: NKB
• UDI-Device Identifier: 00643169414846
• UDI-Public: 00643169414846
• 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): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2026
• Device Catalogue Number: 25740018510
• Device Lot Number: CA17K012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 62