MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG 3D PLATE/5X2 CNDSD,1.5 PROFILE; IMPLANT

Catalog Number	92-10562
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Event or Problem Description
It was reported that the plate broke after implantation and needed to be removed in a revision surgery.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.The reported plate breakage could be confirmed because of the results of the visual inspection.The plate¿s dimensions and chemical composition met specifications, but investigation revealed it failed due to low cycle fatigue from one or repeated powerful dynamic overloads, with fracture surfaces showing forced rupture and fatigue breakage.The implant was confirmed to be correctly implanted and functioned as intended according to the instructions for use, designed to last only until bony healing.Based on statistical evaluation, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.

• Brand Name: 3D PLATE/5X2 CNDSD,1.5 PROFILE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 21491052
• Report Number: 0008010177-2025-00026
• Device Sequence Number: 11747775
• Product Code: JEY
• UDI-Device Identifier: 07613154629374
• UDI-Public: 07613154629374
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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?: Yes
• Device Catalogue Number: 92-10562
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown