MAUDE Adverse Event Report: ORTHOFIX MEDICAL INC BONE GROWTH STIMULATOR; PHYSIOSTIM

Model Number	5302
Health Effect - Clinical Codes	Burn(s) (1757); Discomfort (2330)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states that patient had surgery on (b)(6) 2020 to repair a displaced fracture of fifth metatarsal in her right foot.Patient began treating 3 hours per day with physiostim device from (b)(6) 2020 to (b)(6) 2020.Patient experienced discomfort and removed bandages.Patient believes that the physiostim unit had burned her foot.Patient contacted surgeon and was admitted to hospital for iv antibiotic treatments for 2 days.

• Brand Name: BONE GROWTH STIMULATOR
• Common Device Name: PHYSIOSTIM
• Manufacturer (Section D): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 10955637
• Report Number: 2183449-2020-00010
• Device Sequence Number: 16304169
• Product Code: LOF
• UDI-Device Identifier: 18257200131969
• UDI-Public: 18257200131969
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P850007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: 5302
• Device Catalogue Number: 655302-0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2020
• Initial Report FDA Received Date: 12/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR