MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS LP; UNID COCR ROD

Model Number Ø6.0 MM X >120 MM

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

Initial surgery date was (b)(6) 2016.Breakage detected at the 9 month follow-up.Replacement rods were ordered on 15 november 2016.Not returned to manufacturer.

Event Description

Breakage detected at the 9 month follow-up.Replacement rods were ordered on 15 november 2016.

• Brand Name: PASS LP
• Type of Device: UNID COCR ROD
• 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: 6515638
• MDR Text Key: 73790026
• Report Number: 1000432246-2017-00010
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K100297
• 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: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Ø6.0 MM X >120 MM
• Device Catalogue Number: B33226012
• Device Lot Number: 16B0067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 66