MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; PROXIMAL HUMERUS PLATE

Catalog Number	PHPF-1R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instructions for use for the proximal humerus fixation system states the following: "prior to using the proximal humerus fixation system, ensure that none of the following patient conditions are present: active or latent infection, insufficient quantity or quality of bone and/or soft tissue, material sensitivity (if sensitivity is suspected, tests are performed prior to implantation), or patients who are unwilling or incapable of following post operative care instructions." "the devices in the system are not designed to withstand the stress of excessive weight bearing, load bearing, or physical activity." based on the information available, including the patient suffering multiple falls directly onto their implanted proximal humerus plate, loss of screw fixation was likely the result of traumatic events.
Event or Problem Description
A patient fell 3-4 times on their implanted proximal humerus plate construct, resulting in the screws being pulled out of the humeral head and sitting on the glenoid.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: PROXIMAL HUMERUS PLATE
• Manufacturer (Section D): 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: 25382522
• Report Number: 3006742481-2026-00010
• Device Sequence Number: 21197912
• Product Code: HRS
• UDI-Device Identifier: 00841506138428
• UDI-Public: 00841506138428
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K242436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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: Health Professional
• Device Catalogue Number: PHPF-1R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 06/03/2026
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White