MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON X10 CROSSLINK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8110535
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: part # 8110535, lot # gb11f001 visual and functional testing identified that the hex edges of the driver have been worn from what appears to be repeated normal use.The torque release mechanism inside the handle of the driver is functioning.This type of wear is consistent with repeated use over time.
Event or Problem Description
Information was received from healthcare professional via manufacturer representative regarding a patient with lumbar fixation and fusion due to lumbar degeneration.It was reported that the crosslink screw cap was found broken during x-ray before the patient was discharged from the hospital, and a part of the screw cap fell on the epidural of the lumbar spine.The nut of the x10 crosslink was abnormally broken and broke in the patient's body after the surgery.Crosslink remains implanted.There were no patient symptoms reported.No further complications were reported.

• Brand Name: CD HORIZON X10 CROSSLINK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11326619
• Report Number: 1030489-2021-00191
• Device Sequence Number: 16341877
• Product Code: LXH
• UDI-Device Identifier: 00721902738838
• UDI-Public: 00721902738838
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

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: 8110535
• Device Catalogue Number: 8110535
• Device Lot Number: GB11F001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR