MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number G7753500

Device Problem Material Deformation (2976)

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

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 7753500, 510k # k082728, udi# (b)(4) was cleared in the united states.Product analysis results: visually confirmed the mas connector setscrew is broken at approximately the base of the connector hex head.The bottom portion of the implant was missing and not returned for analysis.Microscopic examination of the thread form did not identify thread damage on the returned portion of the implant.Microscopic examination of the fracture surface appears to emanate from the root of the internal thread tooth outward, is roughly parallel with the tooth angulation, with evidence of linear shear lines on the fracture surface.The location of the fracture at the base of the connector head, the fracture surface angulation relative to the thread axis, absence of thread damage and direction of shear lines are consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent posterior fixation surgery at t2-t3 due to cancer metastasized to the spine and internal fixation to treat destruction to the vertebral body.Intra-op, set screw was broken.The set screws were threaded from the root and it was unable to place crosslink and after that unable to remove the set screws.There was a delay of less than 60 minutes in overall procedure time as a result of this event.No patient complications were reported.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9414831
• MDR Text Key: 184900264
• Report Number: 1030489-2019-01371
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G7753500
• Device Lot Number: 0707428W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• 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 Age: 63 YR
• Patient Weight: 70