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

Model Number B33226012-09

Device Problem Break (1069)

Patient Problem Implant Pain (4561)

Event Date 02/24/2021

Event Type  malfunction  

Event Description

Both unid rods are broken in lower lumbar region for this patient.Patient does not recall any specific incident of how the rods broke.The patient has pain in her lower back.

• Brand Name: PASS LP
• Type of Device: UNID ROD
• Manufacturer (Section D): MEDICREA INTERNATIONAL; 5389 route de strabourg; rillieux -la-pape, 69140 ; FR 69140
• Manufacturer Contact: karine trogneux ; 5389 route de strasbourg; rillieux la pape, 69140 ; FR 69140
• MDR Report Key: 11611368
• MDR Text Key: 243817861
• Report Number: 1000432246-2021-00001
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B33226012-09
• Device Lot Number: 0V79NPC1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR