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

Catalog Number 8350294

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2018

Event Type  Injury  

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 Description

It was reported that intra-op, the probe broke.The operating bone was so hard, and hence the probe got stuck in the pedicle and didn't come out.When surgeon attempted to twist it out, it broke and could not be removed from the patient's body.No health damage in the patient was reported.

Manufacturer Narrative

Product analysis result: visual hardness visual observation reveals that the tip of the probe has been broken approx.3.5cm from what appears to be overload.Hardness reveals that the probes are the proper hardness.This is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient had a previous fusion surgery and fell while at rehab, causing the need for a thoracolumbar fusion extension from t10-s1.There was no revision surgery performed to remove the broken part of the product from the patient's body.

• Brand Name: PROBE
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8238884
• MDR Text Key: 132773102
• Report Number: 1030489-2019-00045
• Device Sequence Number: 1
• Product Code: HXB
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8350294
• Device Lot Number: SW11A092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other