MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY

Model Number 283910000

Device Problem No Flow (2991)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Product name: confidence plus cement kit.Product code: 283910000.Lot/batch/exp: unknown ¿ all packaging discarded.Was the product being used in a clinical trial? no.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? no.Event outcome/how was it managed? another box of cement was opened and used.Was there any consequence to the patient due to the event? no.Was the surgery prolonged due to the event? if yes, confirm how many minutes delay? fifteen mins approx.Has the reporter facility indicated there may be legal action? no.Is the product available for return? no ¿ all components discarded.Please give a detailed explanation of the event: defective mix of cement leading to inability to dispense correctly ¿ another box was opened and the procedure was completed.

• Brand Name: CONFIDENCE SPINAL CMT SYS, 11C
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7432587
• MDR Text Key: 106027560
• Report Number: 1526439-2018-50360
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: (01)10705034209623
• Combination Product (y/n): N
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283910000
• Device Catalogue Number: 283910000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2018
• 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