MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFLATE BALLOON/LARGE- STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Model Number	03.804.702S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: hrx.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 (b)(6) 2018, patient underwent a vertebral body procedure.During the procedure, the synflate balloon malfunctioned.The surgeon placed the synflate balloon into the vertebral body through the pedicle, inflated the balloon, then deflated the balloon until the bubbles stopped coming.He tried to pull out the balloon and felt resistance and stopped.Tried again and felt resistance then stopped, and then rotated the balloon.Surgeon was able to pull out the balloon.At this point the surgeon put the synflate balloon on the scrub table and noticed that 20 % of the balloon was left in the patient.No harm was done to the patient and the surgeon was able to fill the void in the vertebral body with cement.Patient and surgery outcome were not reported.Concomitant devices reported: balloon inflation system (part# unknown, lot# unknown, quantity:1).This report is for one (1) synflate balloon/large- sterile.This is report 1 of 1 for (b)(4).

• Brand Name: SYNFLATE BALLOON/LARGE- STERILE
• Common Device Name: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7310702
• Report Number: 2939274-2018-50843
• Device Sequence Number: 11029581
• Product Code: NDN
• UDI-Device Identifier: 10705034722726
• UDI-Public: (01)10705034722726(17)EXPIRATIONDATEUNKNOWN(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130146
• 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): 02/02/2018

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: 03.804.702S
• Device Catalogue Number: 03.804.702S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 03/02/2018
• 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
• Patient Age: 80 YR