MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFLATE BALLOON/SMALL- STERILE; CEMENT, BONE, VERTEBROPLASTY

Model Number	03.804.700S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part # 03.804.700s, synthes lot # 82221766, supplier lot # 82221766, release to warehouse date: 23 jun2021, expiration date: 30 apr2023, supplier: confluent medical technologies, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2021, a patient underwent a kyphoplasty procedure.During the procedure the surgeon had an issue of getting vertecem balloon to inflate.Surgeon thought maybe something wrong with attachment to balloon.Surgeon was able to get it inflated enough to restore the height.The procedure was completed successfully with a slight delay.Patient outcome is unknown.This report is for one (1) synflate balloon/small- sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SYNFLATE BALLOON/SMALL- STERILE
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12569230
• Report Number: 2939274-2021-05894
• Device Sequence Number: 19663810
• Product Code: NDN
• UDI-Device Identifier: 10705034722702
• UDI-Public: (01)10705034722702
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K130146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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 Expiration Date: 04/30/2023
• Device Model Number: 03.804.700S
• Device Catalogue Number: 03.804.700S
• Device Lot Number: 82221766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1