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
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Misassembled During Installation (4049)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/05/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3001406084-2022-00005
• Device Sequence Number: 12387651
• Product Code: HRS
• UDI-Device Identifier: 04042409363221
• UDI-Public: (01)04042409363221(11)160106(10)I031
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White