ACISRecalls & reported problems across all models
Synthes GmbH · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 78
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls
- 0
We found 14 models of ACIS by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2017 and Feb 10, 2022 — classified as 76 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported ACIS problems
Device problems
- Adverse Event Without Identified Device or Use Problem76
- Device-Device Incompatibility2
Patient problems
- Pain51
- Dysphagia/ Odynophagia41
- Muscular Rigidity7
- Numbness5
- Hematoma4
- Nerve Damage4
- Fatigue3
- No Code Available2
ACIS models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACIS 08.843.008Intervertebral fusion device with bone graft, cervical26 reports
- ACIS 08.843.007Intervertebral fusion device with bone graft, cervical13 reports
- ACIS 08.843.009Intervertebral fusion device with bone graft, cervical10 reports
- ACIS 08.843.007SIntervertebral fusion device with bone graft, cervical9 reports
- ACIS 08.843.008SIntervertebral fusion device with bone graft, cervical5 reports
- ACIS 08.843.607SIntervertebral fusion device with bone graft, cervical3 reports
- ACIS 03.841.059ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- ACIS 03.841.060ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- ACIS 08.843.012Intervertebral fusion device with bone graft, cervical2 reports
- ACIS 08.843.608SIntervertebral fusion device with bone graft, cervical2 reports
- ACIS 03.841.050ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ACIS 08.843.010Intervertebral fusion device with bone graft, cervical1 report
- ACIS 08.843.011SIntervertebral fusion device with bone graft, cervical1 report
- ACIS 08.843.012SIntervertebral fusion device with bone graft, cervical1 report
Recent ACIS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN ACDF C4/5 POSSIBLE REMOVAL OF EXISTING PLATE, THE SURGEON WAS USING ACIS SET TO IMPLANT AN ACIS PRO TI CERVICAL GRAFT. HE INSERTED THE IMPLANT AND UPON REMOVAL OF THE INSERTER REALIZED IT WAS IN TOO FAR. HE LOST MOTORS ON THE PATIENT BELOW THE CHEST. (NO EQUIPMENT BROKE OR MALFUNCTIONED). HE THEN USED A VARIETY OF INSTRUMENTS TO TRY TO REMOVE THE SPACER WHICH HE WAS ABLE TO DO. A NEW GRAFT WAS PLACED AND THE PLATE WAS IMPLANTED WITH SCREWS. ONCE THE CASE WAS COMPLETED NEURO MONITORING SHOWED THAT ONE SIDE OF HER BODY WAS GETTING SOME MOTOR RESPONSE WHILE THE OTHER SIDE WAS NOT. THERE WAS A SURGICAL DELAY WHEN THE GRAFT HAD TO BE REMOVED. THIS REPORT IS FOR ONE (1) INNER SHAFT W/O STOP F/ACIS INSERT DEV. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: Paralysis
MAUDE report 13508353 ↗InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) AND HAD NOT PROGRESSED VERY WELL.
Patient problems: Paralysis
MAUDE report 13508324 ↗InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) AND HAD NOT PROGRESSED VERY WELL.
Patient problems: Nerve Damage
MAUDE report 13508267 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A TOTAL OF 50 PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36). DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS. POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25). SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5). DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS - THAT
Patient problems: Dysphagia/ Odynophagia; Fatigue; Pain
MAUDE report 12045664 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A TOTAL OF (B)(4)PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID 11: A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID 19: A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS - THAT RES
Patient problems: Dysphagia/ Odynophagia; Pain
MAUDE report 12045648 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -
Patient problems: Dysphagia/ Odynophagia; Fatigue; Pain
MAUDE report 12045638 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -
Patient problems: Pain
MAUDE report 12045625 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -
Patient problems: Dysphagia/ Odynophagia; Pain
MAUDE report 12045578 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6) A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -
Patient problems: Pain
MAUDE report 12045566 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A TOTAL OF 50 PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS ID 70: A 71-YEAR-OLD PATIENT (BMI = 38.36). DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS. POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS ID 11: A 78-YEAR-OLD PATIENT (BMI = 25.25). SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS ID 19: A 64-YEAR-OLD PATIENT (BMI = 28.5). DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS - THAT RESOLVED BEF
Patient problems: Dysphagia/ Odynophagia; Fatigue; Pain
MAUDE report 12045559 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -
Patient problems: Dysphagia/ Odynophagia
MAUDE report 12045545 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem
A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -
Patient problems: Bone Fracture(s); Chest Pain; Cramp(s) /Muscle Spasm(s); Dysphagia/ Odynophagia; Fall; Head Injury; Hematoma; Implant Pain; Muscle Weakness/Atrophy; Neck Pain; Neck Stiffness; Nerve Damage; Numbness; Pain; Paresthesia; Twitching
MAUDE report 12045542 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A TOTAL OF (B)(4) PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING WERE REPORTED IN THE AI (SOME PATIENTS CANNOT BE IDENTIFIED WHICH AE THEY BELONG AS THE AE/NUMBER OF COUNT REPORTED BELOW DID NOT COINCIDE ABOVE), WHICH WERE AS FOLLOWS: INTRAOPERATIVE SAGITTAL MIDLINE NONDISPLACED FRACTURE THROUGH C5 VERTEBRAL BODY: DEVICE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 71-YEAR-OLD PATIENT (BMI = 38.36) DEEP VEIN THROMBOSIS: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS POST-OPERATIVE DELIRIUM: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 78-YEAR-OLD PATIENT (BMI = 25.25) SYNCOPE EPISODE: PROCEDURE RELATED: 1 PATIENT - THAT RESOLVED BEFORE 3 MONTHS - ID (B)(6): A 64-YEAR-OLD PATIENT (BMI = 28.5) DYSPHAGIA: PROCEDURE RELATED: 17 PATIENTS -
Patient problems: Numbness; Pain
MAUDE report 12045474 ↗InjuryJun 22, 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 A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) AND DUA DATA LISTING FOR THE ACIS RETROSPECTIVE STUDY COMPLETED AS PART OF THE PMCF PLAN. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS HAVE BEEN IDENTIFIED AS PER CARILLON CLINIC EMR - RETROSPECTIVE REVIEW: ID (B)(6): A (B)(6)-YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYING DOWN; COMPLAINTS OF SOME ISSUES WITH SWALLOWING. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 28.29) EXPERIENCED NECK AND SHOULDER PAIN; SHOULDER AND NECK PAIN CONTINUING. ID (B)(6): A (B)(6)-YEAR-OLD PATIENT (BMI = 34.2) EXPERIENCED DIFFICULTY SWALLOWING SINCE SURGERY HAS IMPROVED; NECK PAIN AND NUMBNESS/ TINGLING DOWN ARMS; HAD COMPLAINTS OF S
Patient problems: Dysphagia/ Odynophagia; Pain
MAUDE report 12044325 ↗InjuryJun 22, 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 A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) FROM CARILION CLINIC. A TOTAL OF 50 PATIENTS IMPLANTED WITH ACIS AND VECTRA DEVICES WERE INCLUDED IN THE STUDY COHORT. THERE WERE MORE MALE PATIENTS (58%) THAN FEMALE PATIENTS (42%). THE MEAN PATIENT AGE WAS 53.5 YEARS (RANGE: 37 TO 84 YEARS). THE MAJORITY OF PATIENTS RECEIVED TREATMENT WITH 2 ACIS DEVICES (54%), FOLLOWED BY 1 ACIS DEVICE (38%), AND 3 ACIS DEVICES (8%). ALL PATIENTS WERE TREATED WITH PEDICLE SCREWS/ RODS (SYNTHES, LTD), AND VECTRA PLATE. THE FOLLOWING COMPLICATIONS AND ADVERSE EVENTS PER IDENTIFIER HAVE BEEN IDENTIFIED AS FOLLOWS IN THE INITIAL REPORT: ID 2: A 42-YEAR-OLD FEMALE PATIENT (BMI = 32.91) REPORTS CONTINUED MUSCLE TIGHTNESS IN NECK SHOULDERS AND TRAPS AND REFERRED TO PAIN MANAGEMENT. THE PATIENT STATES EVER SINCE SURGERY, BILATERAL HANDS WILL RANDOMLY JUMP/TWITCH. SHE ALSO STATED THAT SHE HAS CONTINUED MUSCLE TIGHTNESS AND SORENESS INTO BILATERAL SIDES AND POSTERIOR ASPECTS OF HER NECK. ID 3: A 45-YEAR-OLD PATIENT (BMI = 36.48) EXPERIENCED SHARP PAINS IN NECK, AND BACK; PAIN, DIFFICULTY SWALLOWING; STRANGLING FEELING WHEN LYI
Patient problems: Dysphagia/ Odynophagia; Pain
MAUDE report 12044290 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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