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

Catalog Number 8350316

Device Problem Device Slipped (1584)

Patient Problem Paralysis (1997)

Event Date 08/19/2019

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 the patient underwent placement of screw and bone chip at t11-t12 intervertebral disc space due to ossification of the yellow ligament at t11-t12.Intra-op, for final tightening, when the surgeon attempted to insert the counter torque after the break-off driver was inserted to the plug, the break off driver slipped and contacted with patient's spinal cord.The operation check of mep was performed, and it was reported to be a little weak.After wound closure, when patient's lower extremity movement was checked visually, it moved; so, it was judged that there was no problem.On (b)(6) 2019, the operation room chief nurse reported that the patient is suffering from paralysis.

• Brand Name: SCREWDRIVER
• Type of Device: SCREWDRIVER
• 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: 9080347
• MDR Text Key: 158946091
• Report Number: 1030489-2019-01030
• Device Sequence Number: 1
• Product Code: HXX
• 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
• Report Date: 09/18/2019

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: 8350316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/18/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other