MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC ORTHOLOC 3DI PLATING CHECK SYSTEM; PLATE, FIXATION, BONE

Model Number	58130008
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient had lateral foot pain related to impingement of the evans plate with the peroneal tendons.The patient will undergo a surgery to remove the plate when the patients conditions permits.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient had lateral foot pain related to impingement of the evans plate with the peroneal tendons.The patient will undergo a surgery to remove the plate when the patients conditions permits.

• Brand Name: ORTHOLOC 3DI PLATING CHECK SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 13633596
• Report Number: 3010667733-2022-00111
• Device Sequence Number: 19386350
• Product Code: HRS
• UDI-Device Identifier: 00840420123220
• UDI-Public: 00840420123220
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

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: Lay User/Patient
• Device Model Number: 58130008
• Device Catalogue Number: 58130008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 60
• Patient Sex: Male
• Patient Weight: 85