MAUDE Adverse Event Report: AAP IMPLANTATE AG LOQTEQ® RECONSTRUCTIONPLATE 3.5, 10-HOLE, L 118; BONE PLATE

Model Number PR 3550-10-2

Device Problem Use of Device Problem (1670)

Patient Problem Non-union Bone Fracture (2369)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

In the present case, a reconstruction plate 3.5 mm was used for a midshaft fracture of the clavicle.This indication is usually clinically associated with an increased complication rate.The reconstruction plates from aap are excluded for clavicle mid-shaft fractures this is a late report due to a capa correction.

Event Description

The patient suffered a fracture of the right clavicle.Open reduction with plate and internal screw fixation of the right clavicle fracture was performed on (b)(6) 2021.Postoperative follow-up showed that the fracture was in good alignment.As a result, patients were followed up in a timely manner.Re-examination by x-ray showed that the internal fixation plate of the right clavicle fracture was broken and the fracture had not healed.On (b)(6) 2021, the broken plate was taken out and the fracture fixation was renewed.

• Brand Name: LOQTEQ® RECONSTRUCTIONPLATE 3.5, 10-HOLE, L 118
• 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: 15655458
• MDR Text Key: 302246229
• Report Number: 3001406084-2021-00005
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PR 3550-10-2
• Device Catalogue Number: PR 3550-10-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian