MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; PROXIMAL ULNA PLATE

Model Number Proximal Ulna Plate, 108mm, Right

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Joint Dislocation (2374); Patient Problem/Medical Problem (2688)

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

The system instructions for use warnings state: for safe effective use of the implant, the surgeon must be thoroughly familiar with the surgical technique for the device, implant, and associated instruments.The triceps was not sutured to the proximal ulna plate as suggested by the surgical technique guide, therefore, concluding that the surgical technique guide was not followed.Potential failures of the system may include delayed union, non-union, loosening of fixation, migration or failure of the device, stress fractures of the bones, or incomplete healing as a result of excessive activity, overloading or noncompliance to post-operative rehabilitation.

Event Description

Loss of fixation on the olecranon fracture.Medical intervention needed 1 week post-operation.

• Brand Name: SKELETAL DYNAMICS
• Type of Device: PROXIMAL ULNA PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; miami, fl
• Manufacturer Contact: mehr malek ; 7300 n. kendall drive; miami, fl ; 5967585710
• MDR Report Key: 10292395
• MDR Text Key: 199991711
• Report Number: 3006742481-2020-00004
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841506105802
• UDI-Public: 00841506105802
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Proximal Ulna Plate, 108mm, Right
• Device Catalogue Number: APL-PUP-6HR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR