FDA Adverse Event Malfunction Summary report: N

SKELETAL DYNAMICS INC.

MDR report key: 19093366 · Received April 11, 2024

Report

Report Number: 3006742481-2024-00006
Event Type: Malfunction
Date Received: April 11, 2024
Date of Event: March 13, 2024
Report Date: April 10, 2024
Manufacturer: SKELETAL DYNAMICS INC.
Product Code: KWI
UDI-DI: 00841506100043
PMA / PMN Number: K172688
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE INSTRUCTIONS FOR USE FOR THE ALIGN RADIAL HEAD SYSTEM INCLUDES THE FOLLOWING WARNINGS: "RADIAL HEAD PROSTHESIS CANNOT BE EXPECTED TO WITHSTAND THE ACTIVITY LEVELS AND LOADS OF NORMAL HEALTHY BONE AND JOINT TISSUE. FAILURE OF THE COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION OR EXCESSIVE LOADS (ESTIMATED BODY WEIGHT EQUIVALENT OF 350 LBS OR GREATER)." "THE PATIENT MUST BE CAUTIONED, PREFERABLY IN WRITING, ABOUT THE USE, LIMITATIONS AND POSSIBLE ADVERSE EFFECTS OF THIS DEVICE INCLUDING THE POSSIBILITY OF DEVICE OR TREATMENT FAILURE AS A RESULT OF LOOSE FIXATION AND/OR LOOSENING, STRESS, EXCESSIVE ACTIVITY, OR WEIGHT BEARING OR LOAD BEARING, AND THE POSSIBILITY OF NERVE OR SOFT TISSUE DAMAGE RELATED TO EITHER SURGICAL TRAUMA OR THE PRESENCE OF THE DEVICE." IN THE YEARS FOLLOWING INITIAL IMPLANTATION, THE PATIENT ENGAGED IN 'HARDCORE' ACTIVITY. COMPOUNDED BY THE PATIENT'S POTENTIAL OBESITY, THE RADIAL HEAD CONSTRUCT WAS LIKELY STRESSED, CAUSING THE SET SCREW AFFIXING THE RADIAL HEAD TO THE RADIAL STEM TO BACK OUT.

Description of Event or Problem · 0

THE SET SCREW BACKED OUT OF AN IMPLANTED ALIGN RADIAL HEAD, REQUIRING REVISION SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1125531	SKELETAL DYNAMICS INC.	ALIGN RADIAL HEAD SYSTEM	KWI	SKELETAL DYNAMICS INC.		AN2002019	00841506100043

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR	Female	Required Intervention