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

Catalog Number	7751101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis: pseudo repair for failed hardware c2-c7 posterior cervical fusion procedure: original posterior cervical fusion from c2-c7 was performed approximately 2 years ago.Posted screws were placed in c2 with small connectors.At first post op follow up (6 weeks) the connector had failed and broke in the patient.It was reported that the product was implanted roughly 2 years ago.Post-op, the connector had failed and broke in the patient.Solid fusion was not achieved.Additional surgery was performed as a result of the event for removal.
Additional Manufacturer Narrative
Additional info: product analysis: the connector was returned missing two components: (b)(4) and (b)(4).The connector has been pulled apart.Component (b)(4) appears to have been forcibly pulled apart from (b)(4).The returned components were reassembled and held in place.It would appear that overload from a linear pulling force caused the connector to separate.If information is provided in the future, a supplemental report will be issued.

• 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: 7780867
• Report Number: 1030489-2018-01142
• Device Sequence Number: 19085585
• Product Code: KWP
• UDI-Device Identifier: 00613994460097
• UDI-Public: 00613994460097
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K083071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 7751101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: Other; Required Intervention