MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHOPAK TRAY; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number KPT1502

Device Problem Material Rupture (1546)

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

Event Date 11/06/2020

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

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of primary osteoporosis.It was reported that intra-op, during balloon inflation, it was noted that the balloon ruptured and contrast media leaked.After that, no inflation was performed additionally, the cement was filled as it was, but the cavity was not formed well and the cement content was not so filled as compared with the undamaged left cavity.There was no patient complications/symptoms associated with the event.

• Brand Name: KYPHOPAK TRAY
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; SZ 2000
• Manufacturer (Section G): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; SZ 2000
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10913289
• MDR Text Key: 218521602
• Report Number: 2953769-2020-00030
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041454
• 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: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KPT1502
• Device Catalogue Number: KPT1502
• Device Lot Number: 220086493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2020
• 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