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

Catalog Number B33225512

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

The rod broke two years after the initial surgery ((b)(6) 2016).This failure occurred between the last revision ((b)(6) 2017) and (b)(6) 2018.The surgeon believes there is not a fusion at t12-l1 and there is motion at this level which caused the rod failure.Medicrea international is submitting this report on behalf of importer: (b)(4).

Event Description

The rod broke two years after the initial surgery ((b)(6) 2016).This failure occurred between the last revision ((b)(6) 2017) and (b)(6) 2018.The surgeon believes there is not a fusion at t12-l1 and there is motion at this level which caused the rod failure.

• Brand Name: PASS LP
• Type of Device: UNID 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
• MDR Report Key: 7510269
• MDR Text Key: 108374978
• Report Number: 1000432246-2018-00006
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: B33225512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2018
• 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: 71 YR