MAUDE Adverse Event Report: ASP IMPLANTE AG LOQTEQ HTO PLATE 4.5; BONE PLATE

Model Number PO 4560-01-2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

Locking screws failed approximately one year after high tibia osteotomy surgery.The screw heads of two proximal locking screws which fixed the plate broke off.

Manufacturer Narrative

The surgeon did not follow the surgery technique.He did not use the forth screw in the proximal part of the plate.This screw gives the plate the stability against rotation and usually should avoid such kind of failure that occurred.The surgeon has been informed about the necessity of this screw but he did not accept our hint.Nevertheless we will conduct further evaluation of the implant with regard to material compliance.

• Brand Name: LOQTEQ HTO PLATE 4.5
• Type of Device: BONE PLATE
• Manufacturer (Section D): ASP IMPLANTE AG; berlin ; GM
• Manufacturer Contact: marc seegers ; lorenzweg 5; berlin 12099 ; GM 12099 ; 307501192
• MDR Report Key: 4806156
• MDR Text Key: 19988734
• Report Number: 8043862-2015-00004
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/20/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: PO 4560-01-2
• Device Lot Number: I014
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2014
• 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: 54 YR