MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number K09A

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2016

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that intra-op, balloons ruptured.It may have been because of spurs on patient's end-plate and posterior vertebral body.The contrast agent was not completely sucked out after the breakdown.Bone cement injection was not up to the planned effect (1.55cc/ every vertebral body).No patient complications were reported.No information regarding patient being allergic to the contrast media was reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional info: product analysis: the reported complaint of a balloon rupture was confirmed during product evaluation.Visual examination identified a radial tear was observed near the proximal peak of the balloon.This observation is consistent with rupture due to contact with bone splinters during instrument usage.Due to the ¿umbrella¿ effect of the radially cut ibt, the ibt was unable to be collapsed and removed from the stylus.The above observations are consistent with intraoperative instrument damage.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer (Section G): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6204511
• MDR Text Key: 63262495
• Report Number: 2953769-2016-00092
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00858196001161
• UDI-Public: 00858196001161
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2018
• Device Catalogue Number: K09A
• Device Lot Number: 0008107340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2016
• 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 Age: 58 YR