MAUDE Adverse Event Report: AAP IMPLANTATE AG LOQTEQ® BROAD PLATE 4.5, 10 HOLES, L 186; BONE PLATES

Model Number PG 4556-10-2

Device Problem Use of Device Problem (1670)

Patient Problem Non-union Bone Fracture (2369)

Event Date 09/29/2019

Event Type  Injury  

Manufacturer Narrative

According to the available information, the plate was applied anteriorly to the femur after a previous trauma treatment, presumably as a revision.The treatment from anterior leads to an above-average bending load and high deformation of the plate.It also raises the question of the type and amount of mobilization as early as 14 days post-op.Inspection of the available manufacturing documentation (dhr) shows no discrepancies.The material and fracture analysis could not identify any implant-associated cause of failure.As expected, the fracture was detected at the point of highest stress, the connection of plate to screw.The present fracture is a common shrinkage fracture with subsequent force fracture of the overloaded residual surface.An inclusion found in the vicinity could be clearly excluded as the cause.Finally, the only possible cause is early mobilization, which led to early overloading (low cycle fatigue) of the plate implant.This is a late report due to a capa action.

Event Description

One of the plates - pg 4556 -10-2 was implanted in an 30 years old male 110 kgs with tibia shaft fracture.After 15 days, the patient presented with broken plate.

• Brand Name: LOQTEQ® BROAD PLATE 4.5, 10 HOLES, L 186
• Type of Device: BONE PLATES
• Manufacturer (Section D): AAP IMPLANTATE AG; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• Manufacturer (Section G): AAP IMPLANTATE AG; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• Manufacturer Contact: thomas batsch ; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• MDR Report Key: 15697559
• MDR Text Key: 302686759
• Report Number: 3001406084-2020-00010
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IZ
• PMA/PMN Number: K113648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PG 4556-10-2
• Device Catalogue Number: PG 4556-10-2
• Device Lot Number: K133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White