MAUDE Adverse Event Report: MEDTRONIC STRAIGHT LUMBAR PROBE

Model Number PN9734679

Device Problems Bent (1059); Break (1069); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

Patient undergoing lumbar surgery, with transpedicular screw placement at l5.When utilizing an extra sharp paddle probe very high density bone with osteopetrosis was encountered making it extremely difficult to remove the probe.Strong mechanical effort was used to remove the probe at which point it broke leaving a piece of 1 1/4 inches lodged in the in the vertebral body at the l5 pedicle on the right side.Straight lumbar probe was previously used and tip became bent.Straight thoracic probe was then used which broke off.

• Brand Name: STRAIGHT LUMBAR PROBE
• Type of Device: PROBE
• Manufacturer (Section D): MEDTRONIC; louisville 80027
• MDR Report Key: 3986886
• MDR Text Key: 18292373
• Report Number: MW5037639
• Device Sequence Number: 2
• Product Code: HAW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/01/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PN9734679
• Device Lot Number: 120223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR