MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC OPAL SPACER 10MM X 28MM 11MM HEIGHT-REVOLVE; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	08.803.131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: patient information is not available for reporting.(b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant device is not expected to be returned for manufacturer review/investigation.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.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 transforaminal lumbar interbody fusion (tlif) operation on (b)(6) 2017, a opal spacer 10mm x 28mm 11mm height-revolve broke when the surgeon was trying to implant it in the disc space.The fragments generated due to broken device were easily removed without any additional intervention.There was 10-15 minutes of surgical delay.The surgery was completed with another available device.The patient was stable after the surgery.Concomitant devices reported: unknown plate (part # unknown, lot # unknown, quantity 1).This report is for one (1) opal spacer 10mm x 28mm 11mm height-revolve.(b)(4).

• Brand Name: OPAL SPACER 10MM X 28MM 11MM HEIGHT-REVOLVE
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7179068
• Report Number: 2939274-2018-50151
• Device Sequence Number: 1223003
• Product Code: MAX
• UDI-Device Identifier: 10705034754499
• UDI-Public: (01)10705034754499(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K072791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2017

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 Model Number: 08.803.131
• Device Catalogue Number: 08.803.131
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1