MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC XRL LARGE SHAFT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	03.807.330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth, weight: this information is unknown.Lot number is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during a lateral spinal fusion procedure on (b)(6) 2018, it was discovered that the wrong sized xrl shaft was inserted in an evaluation set.The sales consultant stated he ordered two sets with different sized shafts, one a medium and the other a large.The surgeon was unsure if a medium or a large would be needed in the procedure.However, once the surgery begun, it was confirmed that a medium shaft would be needed.The sales consultant opened the medium set and prepared it for use (attaching the spreader to the shaft and inserting the implant).Almost instantly, the implant fell out of the shaft.The shaft was too big to hold the smaller implant, because it was a large shaft and not a medium shaft.The sales consultant decided to open the large set in hopes that the two were swapped; but, they were not.This incorrect set caused an estimated 10-minute delay in surgery as the surgeon attempted to find another way to complete the surgery without using the originally planned implant.The surgeon decided to implant the patient with an available non-synthes cage and successfully completed the procedure.The patient was reported to be in good condition following the procedure.Reported concomitant devices xrl spreader (part number: 03.807.300, lot number: unknown, quantity: 1), unknown spine implant (part number: unknown, lot number: unknown, quantity: 1).This report is for a xrl large shaft.This is report 1 of 1 for (b)(4).

• Brand Name: XRL LARGE SHAFT
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7549056
• Report Number: 2939274-2018-52329
• Device Sequence Number: 13957782
• Product Code: MQP
• UDI-Device Identifier: 10705034723181
• UDI-Public: (01)10705034723181
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K103320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 03.807.330
• Device Catalogue Number: 03.807.330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/29/2018
• 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: Required Intervention