MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.Without a lot number the device history records review could not be completed.Product was not returned.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 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: ti matrixmidface oblique l-pl 2x3 holes-left/0.8mm thick (part# 04.503.383, 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 one (1) unk - screws: trauma.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10380137
• MDR Text Key: 202094249
• Report Number: 2939274-2020-03426
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE; TI MATRIXMIDFC H-PLT 11 HOLE/0.8MM THK; TI MATRIXMIDFC OBQ 2X3 HOLE-LFT/0.8MM
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR