MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE OBLIQUE L-PL 2X3 HOLES-LEFT/0.8MM THICK; PLATE, BONE

Model Number	04.503.383
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date, the patient underwent an acoustic neuroma resection retrosigmoid procedure.Patient was implanted with an unknown bone plate and putty cement.Postoperatively, the patient developed csf rhinorrhea and was hospitalized for meningitis.The head ct showed pneumocephalus and csf rhinorrhea.The patient was admitted to the hospital and post-operative complications were resolved.Patient outcome is unknown.No further information is available.Concomitant devices reported: unknown screw (part# unknown, lot# unknown, quantity# 1), cranios reinforced fast set putty 3cc-sterile (part# 615.03.01s, lot# dsb7841, quantity# 1), ti matrixmidface h-plate 11 holes/0.8mm thick (part# 04.503.382, lot# unknown, quantity# 1).This report is for 1 ti matrixmidface oblique l-pl 2x3 holes-left/0.8mm thick.This is report 2 of 4 for (b)(4).

• Brand Name: TI MATRIXMIDFACE OBLIQUE L-PL 2X3 HOLES-LEFT/0.8MM THICK
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10380145
• Report Number: 2939274-2020-03425
• Device Sequence Number: 19714926
• Product Code: JEY
• UDI-Device Identifier: 10887587020266
• UDI-Public: (01)10887587020266
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 04.503.383
• Device Catalogue Number: 04.503.383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/07/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE; TI MATRIXMIDFC H-PLT 11 HOLE/0.8MM THK; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR