XRL 08.807.234SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034755427), received between Aug 3, 2021 and Aug 3, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K103320); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: DEML MC, ET AL. (2020), ANTERIOR COLUMN RECONSTRUCTION OF THE THORACOLUMBAR SPINE WITH A NEW MODULAR PEEK VERTEBRAL BODY REPLACEMENT DEVICE: RETROSPECTIVE CLINICAL AND RADIOLOGIC COHORT ANALYSIS OF 48 CASES WITH 1.7-YEARS FOLLOW-UP, EUROPEAN SPINE JOURNAL, VOLUME 29, PAGES 3194¿3202 (SWITZERLAND). THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO EVALUATE WHETHER A NEW PEEK VERTEBRAL BODY REPLACEMENT CAN MAINTAIN THE SAGITTAL ALIGNMENT AS AN ANTERIOR COLUMN RECONSTRUCTION DEVICE IN THORACIC AND LUMBAR SPINAL DEFECTS DUE TO TRAUMA OR TUMOR. BETWEEN AUGUST 2013 TO MAY 2017, 48 PATIENTS WHO UNDERWENT A CORPECTOMY BETWEEN T5 AND L5 DUE TO TRAUMA OR TUMOR AND WERE STABILIZED WITH THE NEW PEEK VERTEBRAL BODY REPLACEMENT WERE INCLUDED IN THE STUDY. THERE WERE 30 MALES AND 18 FEMALES WITH A MEAN AGE OF 43.0+/-15.3 YEARS (RANGE, 18-72). THERE WERE 14 PROCEDURES PERFORMED IN A SINGLE- AND 34 IN A TWO-STAGE-PROCEDURE. FOR ANTERIOR COLUMN RECONSTRUCTION, THE MODULAR, EXPANDABLE UNKNOWN SYNTHES EXPANDABLE XRL PEEK VERTEBRAL BODY REPLACEMENT DEVICE WAS USED. PATIENTS WERE FOLLOWED UP AT 2, 6, 12 AND 24 MONTHS POSTOPERATIVE

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12268374 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103320. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2014 · Apr 8, 2014 · Terminated
  Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is