MAUDE Adverse Event Report: AAP IMPLANTATE AG LOQTEQ® VA VOLARE DIST. RADIUSPLATE 2.5, BROAD, 5-HOLE, L; BONE PLATE

Model Number PR2522-05-2

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Misassembled During Installation (4049)

Patient Problem Non-union Bone Fracture (2369)

Event Date 09/05/2022

Event Type  Injury  

Manufacturer Narrative

The explants (plate/screws) were examined.All parts showed normal signs of use but were undamaged.The threads (plate holes and screws) were intact and functional.The manufacturing and inspection records were examined and showed no discrepancies.Inquiries with the operator revealed the following facts.A fall event cannot be ruled out as the cause, but it cannot be clearly verified due to the patient's dementia.There is also a pronounced osteoporosis, which weakened the screw-bone interface permanently.The reason for the secondary loosening of the screws from the plate is suspected to be the disregard of the following notes and warnings of the accompanying documentation: "warning aap products must not be combined with products of other manufacturers".And "manual tightening to ensure screws plate connection".According to the surgeon, the screws were inserted by machine.The tool used for this is not part of the instrument set of the aap system.The screws were also not tightened manually as intended.No specification deviations could be detected on the implant.The user did not follow the instructions of the surgical technique.The user did not check the screw locking.

Event Description

After treatment of a distal radius fracture, the plate osteosynthesis failed within 4 weeks, resulting in dislocation of the shaft screws.The osteosynthesis was restored in a revision operation using a longer plate.The treated patient (90 years old) has multiple comorbidities (pronounced osteoporosis and dementia).The surgeon could not exclude a fall event.On x-ray on (b)(6) 2022 loosening of the shaft screws could be seen.The revision surgery was performed on (b)(6) 2022.

• Brand Name: LOQTEQ® VA VOLARE DIST. RADIUSPLATE 2.5, BROAD, 5-HOLE, L
• 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: 15562787
• MDR Text Key: 301355967
• Report Number: 3001406084-2022-00005
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04042409363221
• UDI-Public: (01)04042409363221(11)160106(10)I031
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PR2522-05-2
• Device Catalogue Number: PR2522-05-2
• Device Lot Number: I031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White