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

Catalog Number	7752529
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis results: visually confirmed approximately 3mm of instrument tip has been broken off, consistent with interface during usage.The tip just below the fracture has been twisted which is consistent with torsional overload.Inspection of the shaft diameter and material hardness confirmed conformance to print specification.Fracture surface analysis reveals a fairly flat fracture surface and circular material flow, consistent with torsional overload.This type of damage is consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis for this procedure: cervical spine instability type of procedure or technique used: posterior cervical lateral mass fusion from c4-c7 levels implanted: c4-c7 it was reported that intra-op, the mas crosslink connector was successfully secured onto both mas's and the centre nut was tightened.The surgeon used the counter torque and torque set screw driver to "torque off" the locking set screws but when this was done it broke off the top part of the mas connector set screw which remains connected to the locking set screw.There was no way to re-attach the crosslink as the connector set screw was broken off and there was no attachment point to grip onto.The bottom part of the connector set screw was left inside the patient.No malfunction was reported for the alleged crosslink locking screw.No additional treatment or surgery were done as a result of this event.No patient symptoms or complications were reported as a result of this event.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 9502451
• Report Number: 1030489-2019-01453
• Device Sequence Number: 13756886
• Product Code: KWP
• UDI-Device Identifier: 00613994454041
• UDI-Public: 00613994454041
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7752529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR