MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5584150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via manufacturer representative/ distributor regarding a patient having spinal therapy due to spine spondylosis.It was reported that during final fixation of the set screws during the procedure, driver broke.There were no patient complications/ symptoms were reported and the procedure was completed.The product will be returned.There were no further complications reported.On 2020-08-31, update received the procedure involved was spinal fixation spondylisthesis.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10540010
• Report Number: 1030489-2020-01292
• Device Sequence Number: 3027869
• Product Code: LXH
• UDI-Device Identifier: 00643169043664
• UDI-Public: 00643169043664
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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 Model Number: 5584150
• Device Catalogue Number: 5584150
• Device Lot Number: CT17B045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR