MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. AFFIRM INFLATABLE BONE TAMP PACK, ULTRA, 15U

Model Number 658.352S

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/17/2014

Event Type  malfunction  

Event Description

Dr was performing a t-10 kyphoplasty, when it came time to deflate the balloon it would not deflate.Dr had clamped to lumen of the balloon near the proximal end of the working cannula.He remove this clamp prior to attempting to deflate the balloon.He also attached a locking syringe directly to the blue port of the balloon to try and suck out the contrast.He finally grabbed the top of the balloon.He also attached a locking syringe directly to the blue port of the balloon to try and suck out the contrast.He finally grabbed the top of the balloon and forcefully tried to pull it back through the cannula.The balloon then detached from the lumen.The lumen and inner wiring came out and the ruptured balloon stayed inside the patient, inside the vertebral body.Cement was then injected as usual.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned for evaluation, however a review was conducted of all applicable material records, manufacturing records, storage records, and distribution records according to the descriptions of the product used with the concomitant device.All records revealed all product lots were manufactured within specifications, maintained and distributed in accordance with all federal, state an operating procedures.Since the product was not returned for evaluations, the impact of clamping the lumen cannot be accessed, not could the root cause of the failure of the balloon to delate be determined.Closing the lumen of the bone tamp is not mentioned in the affirm literature.The exact cause of the reported issue cannot be ascertained.

• Brand Name: AFFIRM INFLATABLE BONE TAMP PACK, ULTRA, 15U
• Type of Device: AFFIRM INFLATABLE BONE TAMP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave.; audubon PA 19403
• Manufacturer Contact: daniel paul, vp, qa & it ; 2560 general armistead ave.; audubon, PA 19403 ; 6109301800
• MDR Report Key: 3853383
• MDR Text Key: 18364741
• Report Number: 3004142400-2014-00015
• Device Sequence Number: 1
• Product Code: NDN
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 658.352S
• Device Lot Number: GBP283GF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR