XRL 03.807.382Recalls & reported problems
Synthes GmbH · XRL MEDIUM IMPLANT HOLDER · Class 2
All models of XRL (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034723426), received between Dec 13, 2021 and Dec 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Compatibility Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Compatibility Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2021Compatibility Problem; Compatibility Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6)AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, INTRAOPERATIVELY IT WAS NOTICED THAT THE TWO METAL RODS AT THE END OF THE XRL IMPLANT HOLDER ARE BENT AND DO NOT CONNECT ANYMORE. THE INSTRUMENT CANNOT BE USED ANYMORE BECAUSE THE FUNCTION OF THE INSTRUMENT IS NO LONGER GUARANTEED. SURGERY WAS COMPLETED SUCCESSFULLY WITH THE INSTRUMENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT INVOLVES ONE (1) XRL MEDIUM IMPLANT HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12982978 ↗
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 · TerminatedSynthes 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
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page