MAUDE Adverse Event Report: AAP IMPLANTATE AG LOQTEQ® RECONSTRUCTION PLATE 3.5, 7 HOLES, L 82; BONE PLATES

Model Number PR 3550-07-2

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/25/2023

Event Type  Injury  

Event Description

A reconstruction plate was used to treat a mid-shaft fracture of the humerus.The plate broke 10 days after treatment.

• Brand Name: LOQTEQ® RECONSTRUCTION PLATE 3.5, 7 HOLES, L 82
• 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: 18788699
• MDR Text Key: 336338754
• Report Number: 3001406084-2024-00002
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PR 3550-07-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic