MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS LLC FIXATOR, ENDOTINE FOREHEAD BIOABSORBABLE 3.5MM; SCREW, FIXATION, BONE

Model Number 22102

Device Problems Entrapment of Device (1212); Material Fragmentation (1261); Therapeutic or Diagnostic Output Failure (3023); Migration (4003)

Patient Problems Pain (1994); Fluid Discharge (2686); Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2021

Event Type  Injury  

Event Description

Endotine implant removed; in (b)(6) 2020, i had a left endoscopic brow lift procedure.The procedure went well.Within a few weeks, i felt like i had movement around the surgical site.My physician¿s office indicated the endotines had come up from their implanted position, which sometimes occurred, but that they would dissolve.In (b)(6), the endotines were not dissolved, and i met with my physician¿s office again, at this time, we determined that they needed to be removed, and an appointment was scheduled.On (b)(6) 2021 the largest pieces of endotine, which had broken apart and were imbedded in scar tissue were removed.The two following days, my face and neck have been extremely swollen, and there has been discharge from the incision site.There is also a very tender spot in my neck which feels very similar to the endotines which were in my scalp.The swelling in my face has radiated to the right side of my face, back to my ear and neck.My physician is highly skilled, and i believe this is a failed endotine.Fda safety report id # (b)(4).

• Brand Name: FIXATOR, ENDOTINE FOREHEAD BIOABSORBABLE 3.5MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS LLC
• MDR Report Key: 11776571
• MDR Text Key: 249490443
• Report Number: MW5101159
• Device Sequence Number: 1
• Product Code: HWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22102
• Device Lot Number: 324268
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 68