MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG CMRP KIT, SECONDARY,2.8MM,HEMI; IMPLANT

Catalog Number	78-20028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
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 one year after the surgery, the cmrp plate was broken and splintered.
Additional Manufacturer Narrative
Additional information: d6a, d6b, h4, h6.Correction: d9, h3.Device evaluation: follow-up report submitted to document device evaluation results.The reported event was confirmed based on the visual inspection of the returned plate and screws.The fracture analysis revealed low cycle fatigue, forced rupture, and secondary cracks on the plate and screws, caused by excessive bending forces and resulting high traction.Despite proper implantation and patient compliance, the failure was mechanical in nature, with no material or procedural defects identified.Based on the investigation, 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.
Event or Problem Description
No new information.

• Brand Name: CMRP KIT, SECONDARY,2.8MM,HEMI
• 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: 20887908
• Report Number: 0008010177-2024-00136
• Device Sequence Number: 18320338
• Product Code: JEY
• UDI-Device Identifier: 07613252578215
• UDI-Public: 07613252578215
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 78-20028
• Device Lot Number: 2306061006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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