MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS LP; REALIGNMENT CONNECTOR

Catalog Number B02236010

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

Some users have reported that they use the marking as a landmark.To the extent that the position of marking can vary, medicrea draws the attention of surgeons to the need to carefully check the direction of assembly of the realignment connector on the screw head according to its shape (the collar of the connector must be positioned downwards in contact with the screw head) and not according to the position of the marking.The realignment connector is used when a realignment of the vertebra is desired, for example in cases of spondylolisthesis, fracture, and all deformities requiring precise reduction.If the realignment connector is assembled on the wrong side of the screw head: -the tightening of the realignment connector on the screw head is not affected, so the fastening of the assembly is not affected.-the effect of realignment is not ensured and the correction desired by the surgeon could not be performed.No risk on the safety of the device is identified but its efficacy is not optimal.Device not returned to manufacturer.

Event Description

During surgery, customer detected a mistake on the position of the marking (description of ø, reference and lot number) on the realignment connector for ø6.0 mm rod.The realignment connector is asymmetric.

• Brand Name: PASS LP
• Type of Device: REALIGNMENT CONNECTOR
• Manufacturer (Section D): MEDICREA INTERNATIONAL; 5389 route de strasbourg - van; rillieux-la-pape, 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL; 5389 route de strasbourg - van; rillieux-la-pape, 69140 ; FR 69140
• Manufacturer Contact: karine trogneux ; 5389 route de strasbourg - van; rillieux-la-pape, 69140 ; FR 69140 ; 4 72 01 8
• MDR Report Key: 6287925
• MDR Text Key: 66437069
• Report Number: 1000432246-2017-00005
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B02236010
• Device Lot Number: 14I0261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2014
• 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: 38 YR
• Patient Weight: 80