MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON LEGACY 5.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7480144
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
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 provider (hcp) via manufacturer representative regarding patient spinal therapy for thora cic compression fracture.It was reported that the set screw stripped three times at the time of final tightening for one th11 screw.The driver was changed, and it was able to tighten while pushing the rod.The driver was broken and there were no fragments left inside the patient.There were no further complications or symptoms were reported.The procedure involved in the event was th11-l1 anterior fusion.Levels implanted was th11-l1.On (b)(6) 2021 (rep): additional information was received via manufacturer representative that the lot numbers are unknown.There is a possibility of the driver being stripped and reported products were used in the surgical field.On 2021-jun-24 (rep): additional information was received via manufacturer representative that all the three screws were used and stripped in this event.Hence, the pli 30 and pli 40 are added on (b)(6) 2021.

• Brand Name: CD HORIZON LEGACY 5.5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 12134037
• Report Number: 1030489-2021-00902
• Device Sequence Number: 3800457
• Product Code: LXH
• UDI-Device Identifier: 00721902853586
• UDI-Public: 00721902853586
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/08/2021

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: 7480144
• Device Catalogue Number: 7480144
• Device Lot Number: 483270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1