DISTRACTION, INTERNAL, STERILE 25-025-12-71Recalls & reported problems

KLS-Martin L.P. · SPRING, CRANIOXPAND, STAINLESS STEEL ASTM F138/9 · Class 2

All models of DISTRACTION, INTERNAL, STERILE (22)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888118136640), received between Feb 26, 2025 and Feb 26, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Patient-Device Incompatibility1

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryFeb 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
DURING DISTRACTION SURGEON OBSERVED THAT PATIENT ANATOMY LIFTED UP POSTERIORLY MORE THAN SURGEON HAD INTENDED. SURGEON ELECTED TO REMOVE DEVICE AND NOT REPLACE IT.
Patient problems: Insufficient Information
MAUDE report 21468512 ↗

Device details

UDI-DI	`00888118136640`
Brand	DISTRACTION, INTERNAL, STERILE
Model	25-025-12-71
Company	KLS-Martin L.P.
Product code	PBJ · Cranial Distraction System
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jan 2, 2024

Device type (GMDN): Orthopaedic surgical distractor, internal

A hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.

Other Cranial Distraction System devices

DISTRACTION, INTERNAL, STERILE 51-563-30-71
KLS-Martin L.P. · Cranial Distraction System
7 reports
DISTRACTION, INTERNAL, STERILE 51-405-42-71
KLS-Martin L.P. · Cranial Distraction System
6 reports

All Cranial Distraction System devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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