MAUDE Adverse Event Report: AAP IMPLANTATE AG LOQTEQ® NARROW PLATE 4.5, 12 HOLES, L 216 TITANIUM; BONE PLATE

Model Number PG 4555-12-2

Device Problem Use of Device Problem (1670)

Patient Problem Non-union Bone Fracture (2369)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

As a result, there were no deviations from the specification requirements (material, design and manufacturing).Cause: the surgeon used a very rigid construct and screws in the fracture zone.According to the biomechanical principles for locked plating, such designs have a very high risk of implant failure.The radiographs show plate failure in the fracture zone and almost no fracture consolidation, which was obviously the reason for the plate fracture (see also "pitfalls and limitations of locking plates" by jean-christophe bel).A causal involvement of the implant can be excluded.This is a late report due to a capa.

Event Description

Broken bone plate after 2 months of humeral shaft fracture surgery.

• Brand Name: LOQTEQ® NARROW PLATE 4.5, 12 HOLES, L 216 TITANIUM
• Type of Device: BONE PLATE
• 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: 15677513
• MDR Text Key: 302470624
• Report Number: 3001406084-2020-00024
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: K113648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PG 4555-12-2
• Device Catalogue Number: PG 4555-12-2
• Device Lot Number: K138
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2019
• 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): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White