MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON LEGACY 5.5; PROBE

Model Number	803-290
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
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 a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a spinal product using driver and probe for an open tlif.It was reported that the driver and probe were broken.There were no fragments of the instruments remaining in the patient's body.There were no patient symptoms or complications as a result of the event.The pre-op diagnosis was spinal revision and levels implanted were t10-illiac.There was no treatment or additional surgery performed as a result of this event.No further complications were reported/ anticipated.

• Brand Name: CD HORIZON LEGACY 5.5
• Common Device Name: PROBE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 12305770
• Report Number: 1030489-2021-01038
• Device Sequence Number: 3962856
• Product Code: HXB
• UDI-Device Identifier: 00673978035475
• UDI-Public: 00673978035475
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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: 803-290
• Device Catalogue Number: 803-290
• Device Lot Number: SW14J036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR