MalfunctionHXP
UNIVERSAL PLATE BENDER
Received Jul 31, 2025 · Event occurred Jul 8, 2025
Report 2027754-2025-00033 · MDR key 22683351
Device
Generic name
Instrument, Bending Or Contouring
Manufacturer
Osteomed, LlcModel number
220-0575Catalog number
220-0575
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
20 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR INVESTIGATION AND RECEIVED LATE THIS AFTERNOON. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT AT THE CONCLUSION OF THE INVESTIGATION. MDRS FOR THIS COMPLAINT: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT BENDING THE PLATE USING UNIVERSAL PLATE BENDER, ONE OF THE HOLES BROKE. SURGERY WAS COMPLETED WITH A NEW PLATE, SAME SKU. THE DELAY TIME WAS AROUND 30 MINUTES.