NA 04.613.620Recalls & reported problems
Synthes GmbH · 4.0MM TI CERV SELF-RETAIN SCR SLF-TPNG/VARIABLE ANGLE 20MM · Class 2 · Implant
Data updated Oct 16, 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 10705034737850), received between Apr 2, 2018 and Apr 2, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (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 16, 2026.
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- Dysphagia/ Odynophagia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2018Unintended Movement; Unintended Movement
IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2018 FOR TREATMENT OF AN ANTERIOR CERVICAL DISCECTOMY FUSION AT C5-C7 DISC LEVELS DUE TO DEGENERATIVE DISC DISEASE. PATIENT WAS IMPLANTED WITH ONE (1) UNKNOWN VECTRA PLATE AND SIX (6) VECTRA 20MM SELF-TAPPING SCREWS. POST-OPERATIVELY, WITHIN 2 WEEKS OF IMPLANTATION, PATIENT PRESENTED WITH ONE (1) OF THE SCREWS BACKING OUT AT THE PATIENTS LEFT SIDE C5 DISC LEVEL. PRESENTLY, PATIENT HAS DIFFICULTY SWALLOWING. NO REVISION SURGERY HAS BEEN SCHEDULED AT THIS TIME. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. CONCOMITANT DEVICES REPORTED: 4.0MM TI CERVICAL SELF RETAINING/ SELF TAPPING /VARIABLE ANGLE SCREW (PART 04.613.620, LOT NUMBER UNKNOWN, QUANTITY 5), VECTRA PLATE PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.0MM CERVICAL SELF RETAINING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Dysphagia/ Odynophagia
MAUDE report 7390937 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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