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XRL 03.807.315Recalls & reported problems

Synthes GmbH · XRL MEDIUM SPREADER TOP WITH 15MM DISTRACTION · Class 2

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 10705034723174), received between Feb 1, 2019 and Feb 1, 2019 — classified as 1 injury.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device-Device Incompatibility1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryFeb 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE XRL MEDIUM SPREADER TOP WOULD NOT FIT ON THE IMPLANT. THE SURGEON MEASURED THE GAP FROM THE CORPECTOMY AND DECIDED ON THE BEST CAGE AND ENDPLATES. WENT TO SELECT THE CORRESPONDING SPREADER TOP NUMBER 5 AND IT WOULD NOT FIT ON THE XRL MEDIUM CENTRAL BODY IMPLANT. THE XRL MEDIUM SPREADER GIVES THE MOST AMOUNT OF DISTRACTION, IT WAS CALCULATED TO ACHIEVE THE DESIRED HEIGHT THAT WOULD BE NEEDED TO DISTRACT OVER HALF OF THE HEIGHT AVAILABLE FOR THE PARTICULAR IMPLANT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: XRL MEDIUM, CENTRAL BODY, H33MM¿43MM (PART 08.807.207S, LOT UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A XRL MEDIUM SPREADER TOP. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 8296187 ↗

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

Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices

All SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.