MAUDE Adverse Event Report: Orthopediatrics 5.5mm Tap, Navigation

Model Number	01-1800-1055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Serious Injury

• Brand Name: 5.5mm Tap, Navigation
• Common Device Name: 5.5mm Tap, Navigation
• Manufacturer (Section D): Orthopediatrics; 2850 frontier drive; warsaw IN
• Manufacturer (Section G): Orthopediatrics, Corp; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 50952149
• Report Number: 3006460162-2026-00057
• Device Sequence Number: 9534445
• Product Code: OLO
• UDI-Device Identifier: 00841132144718
• UDI-Public: 00841132144718
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203573
• 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): 09/30/2026

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?: Yes
• Device Model Number: 01-1800-1055
• Device Lot Number: 3668-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown