MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PYRAMID ANTERIOR PLATE FIXATION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 8968630

Device Problem Device Damaged by Another Device (2915)

Patient Problem Injury (2348)

Event Date 06/30/2015

Event Type  Injury  

Event Description

The patient underwent a anterior lumbar interbody fusion on l4/l5 due to reduction in disk space.It was reported that intra-op, the tip of screwdriver was very worn.The screws had however, been implanted.Subsequently, in a second surgical intervention, it was decided to remove the screw but it was not possible as the screwdriver was not suitable and the screw head was ruined which did not allow to extract the device.Patient complications were reported as the screws were not removed from the patient.

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Manufacturer Narrative

Corrective info :the inspection check box should not be checked.

• Brand Name: PYRAMID ANTERIOR PLATE FIXATION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• 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: 4941704
• MDR Text Key: 6189348
• Report Number: 1030489-2015-01671
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K013665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8968630
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention