MAUDE Adverse Event Report: MEDICREA INTERNATIONAL UNID ROD COCR Ø5.5 MM; SPINAL ROD

Model Number COCR Ø5.5 MM

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Spinal rod was implanted on (b)(6) 2015.On (b)(6) 2017 the fracture was detected on x-ray.(b)(4).

Event Description

Spinal rod was implanted on (b)(6) 2015.On (b)(6) 2017 the fracture was detected on x-ray.

• Brand Name: UNID ROD COCR Ø5.5 MM
• Type of Device: SPINAL 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: 7126032
• MDR Text Key: 96020347
• Report Number: 1000432246-2017-00023
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141398
• 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: 11/23/2017,12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: COCR Ø5.5 MM
• Device Catalogue Number: B33225512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2017
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 70 YR