MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT; TEMPLATE

Model Number	03.812.308
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Lot number is unknown.Device is an instrument and is 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
Canada reports that during a lumbar fusion with transforaminal lumbar interbody fusion (tilf) on (b)(6) 2018, the end portion of the 8mm transforaminal posterior atraumatic lumbar (tpal) trial spacer sheared off when the surgeon tried to tighten the handle.The fragments were retrieved easily.The surgeon completed the procedure using a different trial size.Surgery was completed successfully with a five (5) minute delay.Patient outcome is fine.Concomitant device: trauma handle (part: unknown, lot: unknown, quantity: 1).This report is for a t-pal trial spacer 10mm x 28mm 8mm height.This is report 1 of 1 for (b)(4).

• Brand Name: T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT
• Common Device Name: TEMPLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7700331
• Report Number: 2939274-2018-52975
• Device Sequence Number: 1040886
• Product Code: HWT
• UDI-Device Identifier: 10705034727837
• UDI-Public: (01)10705034727837
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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 Model Number: 03.812.308
• Device Catalogue Number: 03.812.308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/18/2018
• 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