MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC BALLAST; PROBE

Model Number	25000200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 regarding a patient having unknown indication for bilateral lumbar laminectomy l3-s1 with interbody fusion and other transverse process fusion l3-s1 with iliac wing screws.It was reported that surgeon was placing iliac wing screws and tip broke off (30mm) the probe into patient.The surgeon is not planning a revision surgery to try to retrieve the broken piece at this time there were no patient symptoms/ complications as a result of the event.

• Brand Name: BALLAST
• Common Device Name: PROBE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12786027
• Report Number: 1030489-2021-01360
• Device Sequence Number: 3840297
• Product Code: HXB
• UDI-Device Identifier: 00643169440289
• UDI-Public: 00643169440289
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: 25000200
• Device Catalogue Number: 25000200
• Device Lot Number: CT15M116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female