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

Model Number	25000300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/26/2021
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 healthcare provider (hcp) via a manufacturer representative regarding an event happened during intra-op for a patient undergoing unknown spinal procedure with pre-operative diagnosis of neural foraminal stenosis of lumbar spine, lumbar stenosis without neurogenic claudication, synovial cyst of lumbar faucet joint, lumbar spondylosis with myelopathy.It was reported that, the tip of the ballast probe broke off in the patient¿s ilium and the broken tip was left in the bone.Patient is non smoking, non allergic and had a previous acdf.There was a delay of 3 minutes reported.There was no revision surgery scheduled to retrieve the broken tip left in the bone.No further complications reported.

• Brand Name: BALLAST
• Common Device Name: PROBE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11830150
• Report Number: 1030489-2021-00622
• Device Sequence Number: 14374143
• Product Code: HXB
• UDI-Device Identifier: 00643169623989
• UDI-Public: 00643169623989
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2021

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: 25000300
• Device Catalogue Number: 25000300
• Device Lot Number: CT15M115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 85