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

Model Number B33226012

Device Problem Insufficient Information (3190)

Patient Problem Implant Pain (4561)

Event Date 12/21/2015

Event Type  malfunction  

Manufacturer Narrative

"report was originally submitted within the 30 day timeframe on (b)(6) 2021, however was rejected due to 'duplicate report number' error.The issue has been resolved and the report is being resubmitted.

Event Description

Left crural pain due to a compressive hematoma leading to surgery.Solved without sequelae on the day of the second surgery with the installation of the cages.Patient info: degenerative deformity (b)(6).

• 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 Contact: karine trogneux ; 5389 route de strasbourg; rillieux la pape, 69140 ; FR 69140
• MDR Report Key: 12379747
• MDR Text Key: 268545182
• Report Number: 1000432246-2021-00010
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140738
• 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: 08/20/2021

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: No Information
• Device Model Number: B33226012
• Device Lot Number: C13DB176
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2021
• Initial Date FDA Received: 08/27/2021
• 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 Age: 64 YR
• Patient Weight: 74