MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON® EXPRESS¿ INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number K15A

Device Problem Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/08/2016

Event Type  Injury  

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

Patient demographics: initials-(b)(6), gender-male, age at the time of event: (b)(6) years.Pre-op diagnosis: l2 compression fracture.Levels implanted: l2.It was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty for compression fracture at l2.Physician was taking the balloon out of the vertebral body after deflating the balloon.The balloon ruptured with the markers staying inside of the patients vertebral body and detaching from the device.Physician then injected cement into the body completing the kyphoplasty leaving the remainder of the balloon with the radiopaque markers inside of two per body.It was unknown if there were any adverse affects on the patient.

Manufacturer Narrative

Additional information: x-ray review: fractured implants of kyphoplasty balloon are visible in post/ intra-op x-rays provided.If balloon is over inflated it can ruptured or it can be sheared off against pak needle if not completely deflated before withdrawal.Root cause: surgical technique.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: KYPHON® EXPRESS¿ 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5999234
• MDR Text Key: 56444463
• Report Number: 2953769-2016-00077
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2018
• Device Catalogue Number: K15A
• Device Lot Number: 0008067673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2016
• 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 Outcome(s): Other
• Patient Age: 88 YR