ProDisc-CRecalls & reported problems across all models
Synthes (U.S.A.) LP · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls
- 0
We found 11 models of ProDisc-C by Synthes (U.S.A.) LP in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2018 and Mar 30, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Migration” (6 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
Reports received per month, all models
Most reported ProDisc-C problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Migration6
- Migration or Expulsion of Device2
- Break1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient Device Interaction Problem1
- Unintended Movement1
Patient problems
- No Code Available13
- Pain4
- Failure of Implant2
- Limb Pain2
- Arthritis1
- Calcium Deposits/Calcification1
- Hyperextension1
- Hypersensitivity/Allergic reaction1
ProDisc-C models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ProDisc-C 09.820.025SPROSTHESIS, INTERVERTEBRAL DISC4 reports
- ProDisc-C 09.820.046SPROSTHESIS, INTERVERTEBRAL DISC4 reports
- ProDisc-C 09.820.026SPROSTHESIS, INTERVERTEBRAL DISC3 reports
- ProDisc-C 09.820.035SPROSTHESIS, INTERVERTEBRAL DISC3 reports
- ProDisc-C 09.820.036SPROSTHESIS, INTERVERTEBRAL DISC3 reports
- ProDisc-C 09.820.055SPROSTHESIS, INTERVERTEBRAL DISC2 reports
- ProDisc-C 09.820.045SPROSTHESIS, INTERVERTEBRAL DISC1 report
- ProDisc-C 09.820.056SPROSTHESIS, INTERVERTEBRAL DISC1 report
- ProDisc-C 09.820.065SPROSTHESIS, INTERVERTEBRAL DISC1 report
- ProDisc-C 09.820.066SPROSTHESIS, INTERVERTEBRAL DISC1 report
- ProDisc-C 09.820.076SPROSTHESIS, INTERVERTEBRAL DISC1 report
Recent ProDisc-C adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Migration
A PATIENT (42YO, FEMALE) WAS IMPLANTED WITH A PDC DEVICE ON (B)(6) 2019. THE PATIENT DEVELOPED MYELOPATHY AND IT WAS FOUND THAT THE IMPLANT HAD MIGRATED AND PATIENT WAS EXPERIENCING OSTEOLYSIS. THE IMPLANT WAS REMOVED ON (B)(6) 2026. THE REMOVAL SURGEON DOES NOT BELIEVE THE MYELOPATHY IS CAUSED BY THE DEVICE.
Patient problems: Osteolysis
MAUDE report 24708858 ↗InjuryMay 8, 2025Migration; Migration
A PATIENT WAS IMPLANTED WITH TWO PRODISC C IMPLANTS ON (B)(6) 2020. PATIENT BEGAN TO COMPLAINT OF ARM PAIN AND IT WAS FOUND THAT THE ONE IMPLANT HAD SHIFTED POSTERIOR. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE SURGEON IMPLANTED A FIBULAR STRUT WITH FOUR HOLE PLATE.
Patient problems: Limb Pain
MAUDE report 21984886 ↗InjuryMay 8, 2025Migration; Migration
A PATIENT WAS IMPLANTED WITH TWO PRODISC C IMPLANTS ON (B)(6) 2020. PATIENT BEGAN TO COMPLAINT OF ARM PAIN AND IT WAS FOUND THAT THE ONE IMPLANT HAD SHIFTED POSTERIOR. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE SURGEON IMPLANTED A FIBULAR STRUT WITH FOUR HOLE PLATE.
Patient problems: Limb Pain
MAUDE report 21984885 ↗InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT WAS IMPLANT WITH A PRODISC C IMPLANT AT C4-5, NO INFORMATION IS KNOWN ABOUT THE IMPLANTATION. PATIENT WAS EXPERIENCING HYPERMOBILITY AND THE SURGEON REMOVED THE IMPLANT AND FUSED THE PATIENT ON (B)(6) 2024.
Patient problems: Hyperextension
MAUDE report 20441413 ↗InjuryNov 30, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ON (B)(6) 2021 A PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C5-6. THE PATIENT COMPLAINED OF NECK PAIN AND RIGHT SIDED RADICULOPATHY PAIN. IT WAS FOUND THAT THE SUPERIOR ENDPLATE SHOWED SUBSIDENCE AND INSTABILITY. THE PDC DEVICE WAS REMOVED ON (B)(6) 2023, PATIENT WAS REVISED TO A CAGE AND PLATE SYSTEM.
Patient problems: Neck Pain
MAUDE report 18237495 ↗InjuryJun 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C5-6 ON (B)(6) 2021. THE IMPLANT WAS REMOVED ON (B)(6) 2023. NO STATED REASON FOR REMOVAL WAS PROVIDED, X-RAY IMAGES WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17049194 ↗InjuryJul 1, 2019Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF A PRODISC-C IMPLANT DUE TO PAIN AND AN INFERIOR ENDPLATE MIGRATION WAS OBSERVED. INITIALLY, THE PATIENT HAD IMPLANTATION ON (B)(6) 2018. HOWEVER, THE PDC BALL AND SOCKET WAS DISLODGED AND NO LONGER IN CONTACT. THUS, THE PDC WAS REPLACED WITH A CENTINEL ANTERIOR PLATE AND INTERBODY CAGE. THE PATIENT HAD FACET PAIN THAT WAS INJECTED TWICE (2X) PRIOR TO THE PDC REMOVAL. THE PATIENT HAD HETEROTOPIC OSSIFICATION AT THE PDC LEVEL AND ALSO HAD PRIOR FUSION AT C 5-6 AND C 6-7 USING AN ROI-C (LDR) DEVICE. THE PATIENT'S BONE QUALITY WAS GOOD. AN EXPLANTED DEVICE WAS SUCCESSFULLY RETRIEVED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Calcium Deposits/Calcification; Pain
MAUDE report 8748256 ↗InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT C4/C5 PRODISC-C REMOVAL, DUE TO CONTINUED PATIENT PAIN AND FACET ARTHROSIS. ORIGINALLY, THE PATIENT UNDERWENT PDC IMPLANTATION ABOUT 6 YEARS AGO. THE PDC IMPLANT WAS SUCCESSFULLY EXPLANTED AND THE PATIENT WAS REVISED TO DEPUY SYNTHES ZERO-P FUSION, STAND-ALONE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT MEDIUM DEEP 5MM STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Arthritis; No Code Available; Pain
MAUDE report 8718847 ↗InjuryJun 19, 2019Migration; Migration
UPDATED EVENT : CONCOMITANT DEVICE REPORTED: PRODISC-C IMPLANT EXTRA LARGE 5MM- STERILE (PART #: 09.820.065S, LOT #: H505740, QUANTITY: 1).
Patient problems: No Code Available
MAUDE report 8713425 ↗InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT C5/C6 PRODISC-C REMOVAL DUE TO CONTINUED PAIN AND RADICULAR SYMPTOMS. ORIGINALLY, THE PATIENT UNDERWENT IMPLANTATION ON, (B)(6) 2013. THE PATIENT DEVELOPED NECK PAIN 2 YEARS AFTER IMPLANTATION AND SURGEON OFFERED TO REMOVE AND FUSE. HOWEVER, THE PATIENT DECIDED TO GO FORWARD WITH CONSERVATIVE MEASURES, EPIDURAL STEROID INJECTIONS, ETC. RECENTLY THE PATIENT HAD INCREASED PAIN AND WENT TO THE SURGEON. LATERAL X-RAY WAS TAKEN ON AN UNKNOWN DATE, AND THE REMOVAL SURGERY WAS SCHEDULED ON (B)(6) 2019. THE IMPLANT WAS SUCCESSFULLY EXPLANTED AND THE PATIENT WAS REVISED TO FUSION USING MEDTRONIC CAGE AND PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT WAS STABLE AFTER THE PROCEDURE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Code Available; Pain
MAUDE report 8480546 ↗InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A C5-C6 PRODISC ARTHROPLASTY AND WAS IMPLANTED WITH THE LARGE PRODISC-C IMPLANT; HOWEVER, WHEN THE PATIENT WOKE UP FROM ANESTHESIA, THEY EXPERIENCED QUADRA PARALYSIS. THE DEVICE WAS REMOVED THE SAME DAY, AND PATIENT WAS REVISED TO FUSION WITH A STAND-ALONE ANTERIOR DEVICE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME WAS DOING BETTER AND CONTINUES TO IMPROVE. THIS REPORT IS FOR A PRODISC-C IMPLANT LARGE DEEP 5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Code Available; Paralysis
MAUDE report 8254164 ↗InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT WAS IMPLANTED WITH PRODISC-C AT C6-C7 ON (B)(6) 2017. PATIENT REPORTED CONTINUED NECK PAIN AND WAS RETURNED TO SURGERY ON (B)(6) 2018 FOR REMOVAL OF THE PRODISC-C IMPLANT AND REVISED TO SPINAL FUSION. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. PATIENT STATUS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Pain
MAUDE report 8055231 ↗InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A PRODISC C REMOVAL ON (B)(6) 2018. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Code Available
MAUDE report 8007350 ↗InjuryOct 23, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT WAS IMPLANTED WITH PRODISC-C AT C5-C6 IN (B)(6) 2014.
Patient problems: No Code Available
MAUDE report 7997860 ↗InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A PRODISC-C REVISION PROCEDURE BECAUSE THERE WAS A BONE SPUR THAT WAS CAUSING STENOSIS. THE PRODISC-C IMPLANT WAS IN GOOD POSITION, BUT THEY COULD NOT DECOMPRESS WITHOUT REMOVING IT. THE IMPLANT WAS SUCCESSFULLY REMOVED AND WITHOUT BONE FRAGMENTS. THE PATIENT WAS REVISED TO A FUSION WITH INTERBODY AND PLATE. THERE WAS NO SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND THERE WERE NO OTHER INTERVENTIONS REQUIRED. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT EXTRA LARGE DEEP 6MM-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Code Available
MAUDE report 7931923 ↗
Other Synthes (U.S.A.) LP products
All Synthes (U.S.A.) LP 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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