MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH HIGH VISC CMW SPINAL CMT, 11CC; CONFIDENCE CEMENT, BONE, VERTEBROPLASTY

Catalog Number 183901001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hypersensitivity/Allergic reaction (1907)

Event Date 04/25/2018

Event Type  Death  

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

Surgeon sent a letter and reported two ((b)(4)) aes with confidence cement: during cement augmented spondylodesis with mi technique and a kyphoplasty of lumbar vertebral body screws were positioned without any complication.In coincidence with introducing the cement with a latency of about five minutes the patient suddenly showed a circulation reaction.The procedure had to be stopped ahead of schedule and needed to be reanimated several times.

• Brand Name: HIGH VISC CMW SPINAL CMT, 11CC
• Type of Device: CONFIDENCE 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: 7574763
• MDR Text Key: 110266299
• Report Number: 1526439-2018-50530
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• PMA/PMN Number: K112907
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 183901001
• Device Lot Number: 8621500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2018
• Date Device Manufactured: 12/07/2017
• 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): Death
• Patient Age: 83 YR