MAUDE Adverse Event Report: IMPLANET IMPLANET SPINE SYSTEM; MONOAXIAL PEDICLE SCREW

Model Number DIAMETER 6 LENGTH 40

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

Account disabled: despite numerous reminders made to account help desk, we were enabled to send the report before.

Event Description

A (b)(6) was operated on (b)(6) 2015 for a posterior vertebral arthrodesis (t11-l3) and l2 vertebrectomy.A pyramesh cage was placed on l2 vertebrectomy with an anterior way (lombotomy).A reoperation was performed on (b)(6) 2015.The material was disassembled with an extension of the montage.

• Brand Name: IMPLANET SPINE SYSTEM
• Type of Device: MONOAXIAL PEDICLE SCREW
• Manufacturer (Section D): IMPLANET; technopole bordeaux montesquie; allee francois magendie; martillac, gironde 33650 ; FR 33650
• Manufacturer Contact: regis le couedic ; technopole bordeaux montesquie; alle francois magendie; martillac, gironde 33650 ; FR 33650 ; 3557995555
• MDR Report Key: 5460539
• MDR Text Key: 39505918
• Report Number: 3007675554-2015-00002
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2020
• Device Model Number: DIAMETER 6 LENGTH 40
• Device Catalogue Number: 150107
• Device Lot Number: DKNY-DKOC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2015
• 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: 15 YR
• Patient Weight: 71