MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON EXPRESS INFLATABLE BONE TAMP

Model Number	KEX152EB
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Patient medical history: osteoporosis pre-operative diagnosis for this procedure: primary osteoporosis with compression fractures at t12, l1, and l2 vertebral bodies levels implanted: t12, l1, l2 it was reported that on (b)(6) 2018, intra-op, ibt (inflatable bone tamp) ruptured at 402 psi and 2cc after coming in contact with a bone shard.The deflated ibt was unable to be pulled back through the cannula.The doctor had to pull out entire trocar and re-access the bone.There was a delay of 5 minutes in overall procedure time; however, the procedure was completed successfully with a new product.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluation summary: visual and optical inspection revealed the instrument was returned with the ibt stuck in the cannula.The balloon of the ibt has been punctured/torn and overlapping the cannula.In its current state it is not able to be pulled back through the cannula.The ibt is made to deflate and pass through the cannula once used.It appears the ibt was punctured with a possible bone spur in the vertebral body causing the balloon to tear and deflate improperly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON EXPRESS INFLATABLE BONE TAMP
• Common Device Name: TAMP
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; parque industrial ei lago; neuchâtel 2000 ; SZ 2000
• MDR Report Key: 8057802
• Report Number: 9612164-2018-03140
• Device Sequence Number: 19284511
• Product Code: HXG
• UDI-Device Identifier: 00643169143777
• UDI-Public: 00643169143777
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K123771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 05/03/2020
• Device Model Number: KEX152EB
• Device Catalogue Number: KEX152EB
• Device Lot Number: 0009183947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 01/23/2021
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1