MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS TULIP GENESIS; PEDICLE SCREW

Catalog Number B36006540; B36006550

Device Problems Nonstandard Device (1420); Material Separation (1562)

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

Event Date 01/20/2020

Event Type  malfunction  

Event Description

A complaint was received which reported that the tulip head of the screw disengaged from the screw shank during insertion.The surgeon noticed the issue when he removed the screwdriver.

• Brand Name: PASS TULIP GENESIS
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): MEDICREA INTERNATIONAL; 5389 route de strasbourg; rillieuz-la-pape 69140 ; FR 69140
• Manufacturer Contact: karine trogneux ; 5389 route de strasbourg; rillieux la pape 69140 ; FR 69140
• MDR Report Key: 9726631
• MDR Text Key: 221030732
• Report Number: 1000432246-2020-00001
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B36006540; B36006550
• Device Lot Number: 19F0227; 19F0229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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): Other
• Patient Age: 57 YR