NA 03.841.009Recalls & reported problems
Synthes GmbH · DOUBLE-SIDED TRIAL SPACER LORDOTIC 9MM/10MM HEIGHT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034732206), received between Feb 5, 2019 and Jun 26, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2019Break; Break
IT WAS REPORTED THAT DURING C5-C7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) ON (B)(6) 2019, THE END OF A DOUBLE-SIDED TRIAL SPACER LORDOTIC BROKE OFF WHEN THE SURGEON WAS REMOVING IT. THE PIECE THAT BROKE OFF LANDED ON THE FLOOR. IT WAS A CLEAN BREAK OUTSIDE OF THE WOUND. THERE WAS NO SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR DOUBLE-SIDED TRIAL SPACER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8734928 ↗MalfunctionFeb 5, 2019Break; Break
IT WAS REPORTED THAT DURING A C4-C7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE ON (B)(6) 2019, A PORTION OF THE DOUBLE-SIDED TRIAL SPACER LORDOTIC BROKE OFF DURING IMPACTION. WHILE TRIALING THE C6-7-DISC SPACE STANDARD ACIS TRIAL, THE OPPOSITE SIDE10MM TRIAL HEAD BROKE OFF AT THE WELD POINT DURING IMPACTION WITH A SMALL MALLET. FRAGMENTS WERE GENERATED BUT WERE REMOVED EASILY. AFTER TWO (2) PREVIOUS LEVELS HAD BEEN IMPLANTED AFTER SIZING, THE CORRECT SIZE FOR IMPLANTATION WAS 9MM, SO THERE WAS NO SURGICAL COMPLICATIONS OR SETBACKS. PROCEDURE WAS COMPLETED AS SCHEDULED. THERE WAS NO SURGICAL DELAYED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: IMPACTION INST: HAMMER/MALLET: SP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DOUBLE-SIDED TRIAL SPACER LORDOTIC 9MM/10MM HEIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8307467 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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.
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