MAUDE Adverse Event Report: MEDICREA INTERNATIONAL LIGAPASS; TENSION PULLEY

Catalog Number A08100200

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

When placing the link around the blade of the vertebra and the connector has been achieved, the tension pulley handle is used to exert a tension on the link and thereby fix the anchor around the vertebra.The tension applied may be sometimes higher than the specified tension and lead to damaging the screw-nut system of the tension pulley handle, which causes jamming or blocking.In the latter case, the finalization of the tension of the link must be conducted by using another tension pulley handle.

Event Description

A jamming or a locking of the tensioning mechanism during the tensioning of the band.To date, this risk has not caused any adverse clinical consequences for any patients.

• Brand Name: LIGAPASS
• Type of Device: TENSION PULLEY
• Manufacturer (Section D): MEDICREA INTERNATIONAL; 5389 route de strasbourg; rillieux-la-pape, 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL; 5389 route de strasbourg; rillieux-la-pape, 69140 ; FR 69140
• Manufacturer Contact: karine trogneux ; 5389 route de strasbourg; rillieux-la-pape, 69140 ; FR 69140 ; 4 72 01 8
• MDR Report Key: 6313073
• MDR Text Key: 67237052
• Report Number: 1000432246-2017-00008
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: A08100200
• Device Lot Number: 14J0393
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 80