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

Model Number 25000300

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11830150
• MDR Text Key: 251735549
• Report Number: 1030489-2021-00622
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00643169623989
• UDI-Public: 00643169623989
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25000300
• Device Catalogue Number: 25000300
• Device Lot Number: CT15M115
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 85