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

Model Number B33226012

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2017

Event Type  malfunction  

Event Description

Presentation of a sciatic in l5: malpositionned screw in s1 observed on a scan + rod too long risk of pjk.Reoperation to remove the s1 screws and to add some sublamar bands on t2.

• Brand Name: PASS LP
• Type of Device: UNID ROD
• Manufacturer (Section D): MEDICREA INTERNATIONAL; 5389 route de strasbourg; vancia; rillieux la pape, 69140 ; FR 69140
• MDR Report Key: 12379737
• MDR Text Key: 283097868
• Report Number: 1000432246-2021-00009
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K140738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 08/27/2021

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: Health Professional
• Device Model Number: B33226012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2021
• Initial Date FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR