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

Catalog Number	25840018580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary #patient demographics- initials- (b)(6), gender- male, date of birth- (b)(6) 1944, weight- (b)(6) kg patient medical history- lumbar stenosis with neurological claudication, degenerative flatback, degenerative scoliosis pre-operative diagnosis- lumbar stenosis with neurological claudication, degenerative flatback, degenerative scoliosis procedure- ballast screws placed in s2 alar levels implanted- s2 alar date of implant- (b)(6) 2018 date of explant- (b)(6) 2019 device status- explanted-complete it was reported that on an unknown date, post-op, the implant broke.Hence on (b)(6) 2019, a revision surgery was performed.No fragments of the implant remaining in the patient body.Patient complications were unknown at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent ballast screws placed in s2 alar due to lumbar stenosis with neurological claudication, degenerative flatback, degenerative scoliosis.Post-op, the implant broke.Hence on (b)(6) 2019, a revision surgery was performed to remove the broken implants.No fragments of the implant remaining in the patient body.No other patient complications were reported due to this event.

• 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: 9796208
• Report Number: 1030489-2020-00269
• Device Sequence Number: 13599721
• Product Code: NKB
• UDI-Device Identifier: 00643169413269
• UDI-Public: 00643169413269
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K153442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 25840018580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial 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: 74 YR
• Patient Weight: 100