MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS MIS; CANNULATED POLYAXIAL PEDICLE SCREW

Model Number Ø5.5 X 45 MM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

This batch was not delivered in us.Not returned to manufacturer.

Event Description

Medicrea has recorded an incident regarding the cannulated polyaxial pedicle screw ø5.5 x 45 mm.This incident concerns the impossibility of introducing the cannulated screw on the k-wire.

• Brand Name: PASS MIS
• Type of Device: CANNULATED POLYAXIAL PEDICLE SCREW
• Manufacturer (Section D): MEDICREA INTERNATIONAL; 5389 route de strasbourg - van; rillieux-la-pape, 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL; 5389 route de strasbourg - van; rillieux-la-pape, 69140 ; FR 69140
• Manufacturer Contact: karine trogneux ; 5389 route de strasbourg - van; rillieux-la-pape, 69140 ; FR 69140 ; 4 72 01 8
• MDR Report Key: 6287917
• MDR Text Key: 66358726
• Report Number: 1000432246-2016-00005
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112493
• 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: 01/27/2017

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 Expiration Date: 11/01/2020
• Device Model Number: Ø5.5 X 45 MM
• Device Catalogue Number: B06015545
• Device Lot Number: 15E0371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2015
• 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: 45 YR
• Patient Weight: 55