MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC TRIMLINE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8756480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2021
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 a distractor in an anterior cervical arthrodesis procedure.It was reported that the distractor broke and there was no fragment remaining in the patient's body.There were no patient symptoms or complications as a result of the event.The event did not lead to or extend patient hospitalization.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.There was no treatment or additional surgery performed as a result of this event.No further complications reported/ anticipated.

• Brand Name: TRIMLINE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 12552973
• Report Number: 1030489-2021-01224
• Device Sequence Number: 4103047
• Product Code: LXH
• UDI-Device Identifier: 00681490520126
• UDI-Public: 00681490520126
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/30/2021

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: 8756480
• Device Catalogue Number: 8756480
• Device Lot Number: PM17A008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2021
• Initial Report FDA Received Date: 09/30/2021
• 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