MAUDE Adverse Event Report: Stryker Leibinger Freiburg CMRP, PRIMARY, 2.0MM, HEMI; PLATE, BONE

Catalog Number	78-30020
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: CMRP, PRIMARY, 2.0MM, HEMI
• Common Device Name: PLATE, BONE
• 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: tanja büchel ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 50929173
• Report Number: 0008010177-2026-00184
• Device Sequence Number: 13143050
• Product Code: JEY
• UDI-Device Identifier: 07613252599647
• UDI-Public: 07613252599647
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Device Catalogue Number: 78-30020
• Device Lot Number: 2408121069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• 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 Sex: Unknown