MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYOSTEOTOMY; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Device Problems Use of Device Problem (1670); Device Ingredient or Reagent Problem (2910)

Patient Problems Bacterial Infection (1735); Cyst(s) (1800); Foreign Body In Patient (2687)

Event Date 05/11/2013

Event Type  Injury  

Event Description

Reporter calling, stating that she had a bacterial infection, plastic particles embedded in her bone, and bone cysts after an "experimental" device was used on her during an ankle surgery.Reporter states the ! myosteotomy system was improperly used, and resulted in larger and wider surgical incisions than were necessary in addition to "plastic particles" from the "30 printed device" being shed into her body during surgery, causing bacterial infection and embedding in her ankle bone.Reporter states she has difficulties walking today due to the use of this system and the resulting complications.Reporter states she would like the fda to investigate the myosteotomy system and "contact the swiss authorities" because it is not safe to use on patients.

Event Description

Add'l info received from the reporter on 04/24/2024 for report number: mw5147164.Reporter calling, stating that she had a bacterial infection, plastic particles embedded in her bone, and bone cysts after an "experimental" device was used on her during an ankle surgery.Reporter states the myosteotomy system was improperly used, and resulted in larger and wider surgical incisions than were necessary in addition to "plastic particles" from the "30 printed device" being shed into her body during surgery, causing bacterial infection and embedding in her ankle bone.Reporter states she has difficulties walking today due to the use of this system and the resulting complications.Reporter states she would like the fda to investigate the myosteotomy system and "contact the swiss authorities" because it is not safe to use on patients.

• Brand Name: MYOSTEOTOMY
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA
• MDR Report Key: 17975461
• MDR Text Key: 326255830
• Report Number: MW5147164
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female