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

Catalog Number	G7755124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Neck Pain (2433)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Part# g7755124 is not marketed in us but a similar device with part# 7755124, 510(k): k082728 is marketed in us.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Submitted post-op x-rays showed rod fracture in occipital cervical fusion.There were multiple stripped segments in the construct which would have predispose the construct to failure if fusion had not occurred.
Event or Problem Description
The patient underwent posterior cervical fusion at oc-c6.Post-op, the patient complained of pain at cervical.Patient underwent x-ray which revealed breakage of connector part of the adjustable rod at oc-c2.This caused protrusion of rod and pain.The broken rod was scheduled to be removed on (b)(6) 2017.No information regarding revision surgery was made available.

• 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: 6897711
• Report Number: 1030489-2017-02122
• Device Sequence Number: 761086
• Product Code: KWP
• UDI-Device Identifier: 00613994667199
• UDI-Public: 00613994667199
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: G7755124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention