MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 2980001

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).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.

Event Description

It was reported that intra-op, the tightening knob on the inserter had come off the threaded inserter portion and could not be tightened back.The cage was implanted successfully but the instrument came apart when removing it from the implant.The instrument came in contact with the patient.No patient complications were reported.

Manufacturer Narrative

Additional information: product analysis:visual review confirms inner threaded shaft, set screw, and knob disassembled as received.Visual and optical examination of the threaded inner shaft identified clear set screw witness marks on rod face, consistent with proper assembly and sufficient tightening.Returned components were able to be re-assembled together and evaluated and found to be securely attached to re-assembled inserter.The inserter requires dis-assembly for proper cleaning and sterilization after usage.The above observations are consistent with inadequate tightening of knob set screw after cleaning, sterilization and attempted re-assembly.

• Brand Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5136360
• MDR Text Key: 28110850
• Report Number: 1030489-2015-02599
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K073291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2980001
• Device Lot Number: DC09J181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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