MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; PROTEAN FRAGMENT PLATE (DOUBLE HOCKEY STICK, CENTRAL COLUMN PLATE)

Catalog Number	PRT-FSP-LR, PRT-CCP-RT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the protean fragment plate system includes the relevant precaution: "the fragment plate system is to be used only with skeletal dynamics instruments, implants and accessories." the decision to use third party instrumentation likely negatively impacted the appropriate drill trajectories for the plates, unnecessarily stressing both the screws and the plates.
Event or Problem Description
Two implanted protean fragment plates and the screws holding them in place broke three months following initial implantation, requiring revision surgery.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: PROTEAN FRAGMENT PLATE (DOUBLE HOCKEY STICK, CENTRAL COLUMN PLATE)
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 800; miami, FL 33156 ; 3055967585
• MDR Report Key: 19101887
• Report Number: 3006742481-2024-00007
• Device Sequence Number: 20650013
• Product Code: HRS
• UDI-Device Identifier: 00841506102917
• UDI-Public: 00841506102917
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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
• Device Catalogue Number: PRT-FSP-LR, PRT-CCP-RT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White