MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC OPAL SPACER 10MM X 32MM 10MM HEIGHT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	08.803.210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient information not available for reporting.Additional product code: mqp.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.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.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 on (b)(6) 2018, an opal spacer broke into multiple fragments during an initial implantation.It is unknown as to how the opal spacer broke.All broken pieces (fragments) were retrieved by the surgeon successfully and skillfully.The surgeon then implanted another spacer (same part) along with unknown quantity of pedicle screws to conclude the surgery by closing the patient.There was no adverse consequence to the patient.The surgery was delayed by about two to three (2-3) minutes.Multiple fluoroscopic images were taken throughout the procedure.The procedure was reported to have been completed successfully and without any additional interventions.The patient was reported to be in a stable condition.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: OPAL SPACER 10MM X 32MM 10MM HEIGHT
• 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: 7448281
• Report Number: 2939274-2018-51844
• Device Sequence Number: 1592136
• Product Code: MAX
• UDI-Device Identifier: 10705034754574
• UDI-Public: (01)10705034754574
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2018

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: 08.803.210
• Device Catalogue Number: 08.803.210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1