MAUDE Adverse Event Report: SYNTHES GMBH SYNFLATE BALLOON/LARGE- STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 03.804.702S

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: hrx.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: part #: 03.804.702s.Synthes lot #: h888514.Supplier lot #: h888514.Release to warehouse date: may 18, 2020.Expiration date: feb 01, 2022.Supplier: confluent medical technologies.No ncr's generated during production.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, to inject cement into the vertebra, the surgeon tried to inflate a balloon before inserting it into the patient's body and discovered that the balloon was defective and had a significant leak in the area of the connections - a punch or hole in the plastic.It was unknown the surgery completed successfully.There were no patient consequences are reported.This complaint involves one (1) device.This report is for (1) synflate balloon/ large-sterile this report is 1 of 1 for (b)(4).

• Brand Name: SYNFLATE BALLOON/LARGE- STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12219556
• MDR Text Key: 263498045
• Report Number: 8030965-2021-06056
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819525405
• UDI-Public: (01)07611819525405
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K130146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 03.804.702S
• Device Lot Number: H888514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1