MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC MANUAL ORTHOPEDIC SURGICAL INSTRUMENT; PROBE

Catalog Number 803-292

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to manufacturer for evaluation therefore we are unable to determine definitive cause of event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Fixation range: th2/th9 it was reported that patient underwent posterior decompression and fusion due to ossification of posterior longitudinal ligament (opll).Intra-op, the tip of the straight probe being used in the procedure broke.The fragment of the broken probe remained inside the patient which was confirmed at the right side of l4 by x-ray images.The doctor tried in vain to remove the screw.At that time, the screw may have been pushed forward.Mri revealed that the tip of the probe was in capsula cordis and its posterior portion remained in vertebral body.The fragment remaining inside the patient is planned to be removed on a later date.There was no health damage caused to the patient.As the patient was originally scheduled to be treated by anterior approach at proper intervals, there was no particular problem that raised as a result of this event.

• Brand Name: MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6050130
• MDR Text Key: 58128749
• Report Number: 1030489-2016-02963
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

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: 803-292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/24/2016
• Supplement Dates Manufacturer Received: 10/03/2016
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: No
• 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