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

Model Number B33143600-14

Device Problem Break (1069)

Patient Problem Implant Pain (4561)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

Both rods broke directly at the transition point from 3.5 diameter to 6.0 due to a pseudoarthrosis.Patient is experiencing pain and the patient was admitted on (b)(6) 2021 for revision on (b)(6) 2021.Surgeon states that this is not an instrument failure it is a fusion 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: 12149464
• MDR Text Key: 261022434
• Report Number: 1000432246-2021-00002
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B33143600-14
• Device Lot Number: 0WF6GWC6_2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2021
• 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: 60 YR