InjuryMQN

IPS

Received Jun 5, 2026 · Event occurred May 14, 2026

Report 1000525271-2026-00024 · MDR key 25412536

Device

Generic name

Distractor

Manufacturer

Kls-martin L.p.

Model number

60-008-92-09

Lot number

SEE H11

Product problems

Difficult to Remove

Patient

8 YR · Male

Insufficient Information

Narrative

Additional Manufacturer Narrative

LOTS. 26007309. 26007311.

Description of Event or Problem

IT WAS REPORTED THAT THE IPS MIDFACE DISTRACTORS DID NOT ADVANCE AS EXPECTED, RESULTING IN DIFFICULTIES DURING REMOVAL. THEY WERE REMOVED AND REPLACED WITH ALTERNATE FIXATION PRODUCTS. DISTRACTORS WERE INTACT AND UNDAMAGED UPON EXPLANT.