Mariner MD1-100016Recalls & reported problems
Seaspine Orthopedics Corporation · PointLock Set Screw · Class 2
All models of Mariner (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Seaspine Mariner set screw is a small piece used to lock spinal hardware in place during back surgery. Reports mostly describe trouble seating or tightening the screw, damaged threads, and screws loosening or coming off afterward, sometimes delaying surgery or requiring another operation. There are 25 reports that mention this identifier, with no deaths and 4 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10889981283803), received between Apr 14, 2022 and Apr 14, 2026 — classified as 4 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Migration” (17 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Migration17
- Damaged Thread3
- Difficult or Delayed Positioning2
- Premature Separation2
- Mechanical Problem1
- Off-Label Use1
- Separation Problem1
Patient problems
- Insufficient Information14
- No Clinical Signs, Symptoms or Conditions9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Damaged Thread
ON 23 MAR 2026, SEASPINE/ORTHOFIX WAS MADE AWARE OF A 45-MINUTE SURGICAL DELAY INVOLVING THE MARINER DEFORMITY SPINAL SYSTEM. PER THE REPORTER, THE SURGEON HAD TROUBLE SEATING THE FINAL LEFT L4 SET SCREW INTO A UNIPLANAR EXTENDED TAB SCREW. ADDITIONALLY, THE REDUCERS COULD NOT REDUCE THE ROD FULLY AND DISCONNECTED FROM THE TULIP. ULTIMATELY THE SCREW AND SET SCREW WERE REMOVED AND REPLACED AND THE CASE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR THE ASSOCIATED SET SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879228 ↗InjuryJan 2, 2026Migration
ON 08 DEC 2025, SEASPINE/ORTHOFIX WAS MADE AWARE OF A POST-OPERATIVE SCREW FRACTURE RELATED TO THE MARINER MIS POSTERIOR FIXATION SPINAL SYSTEM. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO CORRECT THE SCREW FRACTURE. NEITHER THE INDEX SURGERY DATE NOR THE REVISION SURGERY DATE FOR THE SCREW FRACTURE WERE PROVIDED. (SEE MDR 3012120772-2025-00071 FOR THIS EVENT). AFTER THE REVISION SURGERY, IT WAS REPORTED THAT A POINTLOCK SET SCREW BACKED OUT/LOOSENED POST-OPERATIVELY, WHICH REQUIRED AN ADDITIONAL REVISION SURGERY. THIS REPORT IS 1 OF 2 BEING FILED TO DOCUMENT THE POST-OPERATIVE SET SCREW BACK OUT /LOOSENING. SEE MDR 3012120772-2025-00073 FOR THE SECOND REPORT RELATED TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23945705 ↗InjuryJan 2, 2026Migration
ON 08 DEC 2025, SEASPINE/ORTHOFIX WAS MADE AWARE OF A POST-OPERATIVE SCREW FRACTURE RELATED TO THE MARINER MIS POSTERIOR FIXATION SPINAL SYSTEM. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO CORRECT THE SCREW FRACTURE. NEITHER THE INDEX SURGERY DATE NOR THE REVISION SURGERY DATE FOR THE SCREW FRACTURE WERE PROVIDED. (SEE MDR 3012120772-2025-00071 FOR THIS EVENT). AFTER THE REVISION SURGERY, IT WAS REPORTED THAT A POINTLOCK SET SCREW BACKED OUT/LOOSENED POST-OPERATIVELY, WHICH REQUIRED AN ADDITIONAL REVISION SURGERY. THIS REPORT IS 2 OF 2 BEING FILED TO DOCUMENT THE POST-OPERATIVE SET SCREW BACK OUT /LOOSENING. SEE MDR 3012120772-2025-00071 FOR THE FIRST REPORT RELATED TO THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23945701 ↗MalfunctionNov 3, 2025Difficult or Delayed Positioning; Damaged Thread; Difficult or Delayed Positioning; Damaged Thread
A PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2025 CONSISTING OF ORTHOFIX/SEASPINE'S MARINER PEDICLE SCREW SYSTEM. IT WAS REPORTED ON (B)(6) 2025, THAT THE THREADS OF A MD1-100016 POINTLOCK SET SCREW FRACTURED DURING FINAL TIGHTENING. ALL THE FRAGMENTS WERE RETRIEVED. THE DEFECTIVE ITEM WAS REMOVED AND REPLACED. THIS RESULTED IN A PROCEDURAL DELAY OF 30 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH BACKUP IMPLANTS. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO COMPLETE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23455475 ↗MalfunctionJul 16, 2025Off-Label Use; Off-Label Use
IT WAS REPORTED ON (B)(6) 2025 THAT THE SURGEON ATTEMPTED TO USE A MARINER SET SCREWS WITH THE MEDTRONIC UNID ROD. WHILE PERFORMING THE DISTRACTION, THE SURGEON HAD TO LOCK DOWN THE MARINER SET SCREWS MULTIPLE TIMES IN ORDER TO ACHIEVE THE DISTRACTION HE NEEDED. BACK-UP WAS NOT NEEDED AS HE WAS ABLE TO GET THE MARINER SET SCREWS TO HOLD DISTRACTION. THE IMPLANT WAS NOT BROKEN, THE ISSUE DID NOT CAUSE A CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT OUTCOME HAS BEEN REPORTED TO DATE. THIS EVENT INVOLVED THE OFF-LABEL USE OF THE MARINER SET SCREWS WITH THE MEDTRONIC UNID ROD, A COMBINATION THAT HAS NOT BEEN VALIDATED OR TESTED FOR CROSS-COMPATIBILITY. NO PATIENT INJURY, EXPLANTATION, OR ADDITIONAL INTERVENTION WAS REQUIRED. AS THE COMBINATION HAS NOT BEEN VALIDATED OR TESTED FOR CROSS-COMPATIBILITY, ORTHOFIX/SEASPINE CANNOT GUARANTEE THE STABILITY OF THE CONSTRUCT POST-OPERATIVELY, THEREFORE, BASED ON THIS RISK CHARACTERIZATION, THE EVENT WAS DETERMINED TO BE REPORTABLE. THE REP CONFIRMED THE UNID ROD AND THE MARINER SET SCREWS WERE LEFT IN-SITU AND ARE NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22526694 ↗MalfunctionJun 23, 2025Difficult or Delayed Positioning; Damaged Thread; Difficult or Delayed Positioning; Damaged Thread
A PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2025 CONSISTING OF ORTHOFIX/SEASPINE'S MARINER PEDICLE SCREW SYSTEM. IT WAS REPORTED ON (B)(6) 2025 THAT THE SURGEON HAD DIFFICULTY PLACING SEVERAL SET SCREWS, RESULTING IN A PROCEDURAL DELAY. THE PROCEDURE WAS ULTIMATELY COMPLETED WITHOUT PATIENT INJURY, AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22307383 ↗MalfunctionJan 7, 2025Migration; Migration
A PATIENT UNDERWENT AN INITIAL SURGERY ON AN UNKNOWN DATE AND WAS SCHEDULED FOR A REVISION ADJACENT LEVEL SURGERY. WHILE PERFORMING THE REVISION SURGERY, THE SURGEON NOTICED THAT A MARINER SET SCREW HAD POPPED OFF POST-OPERATIVELY. CUSTOMER CONFIRMS THERE WAS NO PATIENT INJURY, NO DELAY IN SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DATE OF INITIAL SURGERY AND REVISION SURGERY WERE UNABLE TO BE PROVIDED. ALTHOUGH REQUESTED, THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093776 ↗MalfunctionJan 7, 2025Migration; Migration
A PATIENT UNDERWENT AN INITIAL SURGERY ON (B)(6) 2024 AND WAS SCHEDULED FOR A REVISION ADJACENT LEVEL SURGERY ON (B)(6) 2024. WHILE PERFORMING THE REVISION SURGERY, THE SURGEON NOTICED THAT A MARINER SET SCREW HAD POPPED OFF POST-OPERATIVELY. CUSTOMER CONFIRMS THERE WAS NO PATIENT INJURY, NO DELAY IN SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ALTHOUGH REQUESTED, THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093775 ↗MalfunctionSep 19, 2024Migration; Migration
ON (B)(6) 2024, IT WAS OBSERVED VIA X-RAY THAT THERE WAS A POTENTIAL LOOSENING/MIGRATION OF A MARINER MIS ROD IN A PATIENT. THE SURGEON SCHEDULED A REVISION SURGERY ON (B)(6) 2024. CUSTOMER REPORTS PATIENT IS ASYMPTOMATIC AND THERE WAS NO ALLEGED PATIENT INJURY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. SEE MDR 3012120772-2024-0068 FOR PN MM1-155035, 3012120772-2024-00085 FOR ONE OF THE RETURNED PN MD1-100016, 3012120772-2024-00086 FOR PN MM1-000020 AND 3012120772-2024-00087 FOR PN 41-7555-2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258443 ↗MalfunctionSep 19, 2024Migration; Migration
ON (B)(6) 2024, IT WAS OBSERVED VIA X-RAY THAT THERE WAS A POTENTIAL LOOSENING/MIGRATION OF A MARINER MIS ROD IN A PATIENT. THE SURGEON SCHEDULED A REVISION SURGERY ON (B)(6) 2024. CUSTOMER REPORTS PATIENT IS ASYMPTOMATIC AND THERE WAS NO ALLEGED PATIENT INJURY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED. MDR 3012120772-2024-0068 FOR PN MM1-155035, 3012120772-2024-00086 FOR PN MM1-000020, 3012120772-2024-00087 FOR PN 41-7555-2 AND 3012120772-2024-00088 FOR THE SECOND RETURNED PN MD1-100016.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258239 ↗MalfunctionJun 27, 2024Migration; Migration
ON (B)(6) 2023, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER POSTERIOR FIXATION SYSTEM. ON (B)(6) 2024, THE REPORTER PROVIDED X-RAY IMAGES THAT SHOWED POST-OPERATIVE SET SCREW BACKOUT. REVISION SURGERY IS NOT PLANNED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19629774 ↗MalfunctionJun 21, 2024Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND ON (B)(6) 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. 10 MD1-100016 POINTLOCK SET SCREWS AND 10 MM1-000020 MIS POLYAXIAL HEADS WERE RETURNED; AT THE TIME OF THE INITIAL REPORT IT WAS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR LOT: AW167907B, 3 OF 4 UNITS.
Patient problems: Insufficient Information
MAUDE report 19587598 ↗MalfunctionJun 21, 2024Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND (B)(6) 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. 10 MD1-100016 POINTLOCK SET SCREWS AND 10 MM1-000020 MIS POLYAXIAL HEADS WERE RETURNED; AT THE TIME OF THE INITIAL REPORT IT WAS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR 2 OF 3 UNITS OF LOT AW159774B.
Patient problems: Insufficient Information
MAUDE report 19586830 ↗MalfunctionJun 21, 2024Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND (B)(6) 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. 10 MD1-100016 POINTLOCK SET SCREWS AND 10 MM1-000020 MIS POLYAXIAL HEADS WERE RETURNED; AT THE TIME OF THE INITIAL REPORT IT WAS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR 2 OF 2 UNITS OF LOT AW167909B.
Patient problems: Insufficient Information
MAUDE report 19586560 ↗MalfunctionJun 21, 2024Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND ON (B)(6) 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. 10 MD1-100016 POINTLOCK SET SCREWS AND 10 MM1-000020 MIS POLYAXIAL HEADS WERE RETURNED; AT THE TIME OF THE INITIAL REPORT IT WAS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR LOT: AW167907B, 4 OF 4 UNITS.
Patient problems: Insufficient Information
MAUDE report 19586362 ↗MalfunctionJun 21, 2024Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND (B)(6) 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. 10 MD1-100016 POINTLOCK SET SCREWS AND 10 MM1-000020 MIS POLYAXIAL HEADS WERE RETURNED; AT THE TIME OF THE INITIAL REPORT IT WAS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR 1 OF 1 UNIT OF LOT AW167910B.
Patient problems: Insufficient Information
MAUDE report 19586316 ↗MalfunctionJun 21, 2024Migration; Migration
ON(B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND (B)(6) 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. 10 MD1-100016 POINTLOCK SET SCREWS AND 10 MM1-000020 MIS POLYAXIAL HEADS WERE RETURNED; AT THE TIME OF THE INITIAL REPORT IT WAS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR 1 OF 2 UNITS OF LOT AW167909B.
Patient problems: Insufficient Information
MAUDE report 19585790 ↗MalfunctionJun 21, 2024Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND (B)(6) 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. 10 MD1-100016 POINTLOCK SET SCREWS AND 10 MM1-000020 MIS POLYAXIAL HEADS WERE RETURNED; AT THE TIME OF THE INITIAL REPORT IT WAS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR 3 OF 3 UNITS OF LOT AW159774B.
Patient problems: Insufficient Information
MAUDE report 19585019 ↗MalfunctionJun 21, 2024Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND (B)(6) 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. 10 MD1-100016 POINTLOCK SET SCREWS AND 10 MM1-000020 MIS POLYAXIAL HEADS WERE RETURNED; AT THE TIME OF THE INITIAL REPORT IT WAS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR LOT AW167907B, 2 OF 4 UNITS.
Patient problems: Insufficient Information
MAUDE report 19585009 ↗MalfunctionJun 21, 2024Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND 5 MAY 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. MULTIPLE PRODUCTS WERE EXPLANTED AND RETURNED; IT IS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR 1 OF 3 UNITS OF LOT AW159774B.
Patient problems: Insufficient Information
MAUDE report 19585001 ↗MalfunctionJun 21, 2024Migration; Migration
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MARINER MIS POSTERIOR FIXATION SYSTEM. ON OR AROUND (B)(6) 2024, IT WAS OBSERVED THAT "THERE WAS A TULIP DISENGAGEMENT AND SET SCREW FALL OUT POST OP." REVISION SURGERY OCCURRED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED. 10 MD1-100016 POINTLOCK SET SCREWS AND 10 MM1-000020 MIS POLYAXIAL HEADS WERE RETURNED; AT THE TIME OF THE INITIAL REPORT IT WAS UNKNOWN WHICH UNITS WERE ASSOCIATED WITH THE FAILURE. THIS REPORT IS FOR 1 OF 4 UNITS OF LOT AW167907B.
Patient problems: Insufficient Information
MAUDE report 19584952 ↗MalfunctionNov 15, 2023Premature Separation; Premature Separation
SEASPINE WAS MADE AWARE ON (B)(6) 2023 THAT AN MD1-100016 POINTLOCK SET SCREW DISENGAGED POST-OPERATIVELY FROM S1 AND THE ROD IS NO LONGER ATTACHED. THE INDEX SURGERY WAS PERFORMED ON (B)(6) 2023. THE LOCKING CAP ON S1 FROM HAD DISENGAGED AND THE ROD WAS NO LONGER ATTACHED. WHILE THE CASE SHEET PROVIDED INDICATES ANOTHER SCREW, ADDITIONAL INFORMATION PROVIDED STATES THAT THE SCREW THAT DISENGAGED IS A MD1-100016 POINTLOCK SET SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145138 ↗InjuryOct 7, 2022Separation Problem; Separation Problem
A PATIENT UNDERWENT SPINAL SURGERY, WHICH CONSISTED OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM FROM LEVELS T12-S1. SEASPINE WAS INFORMED ON (B)(6) 2013 THAT ONE OF THE SCREW HEADS AND SET SCREWS SEPARATED FROM THE CONSTRUCT IN THE POSTOPERATIVE PERIOD.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15566759 ↗InjuryMay 7, 2022Mechanical Problem; Mechanical Problem
ON (B)(6) 2022, SEASPINE WAS MADE AWARE THAT A SURGEON REPORTED LIKELY SET SCREW LOOSENING POST-OP. X-RAYS TAKEN APPROXIMATELY 3 MONTHS AFTER THE REVISION SURGERY SHOWS WHAT APPEARS TO BE 3 LOOSE SET SCREWS. THE CUSTOMER NOTED THAT AS OF 07 APRIL 2022, THERE IS NO REVISION SURGERY SCHEDULED FOR THIS PATIENT. NO IMPLANTS WERE MADE AVAILABLE FOR ANALYSIS AS NO REVISIONS HAVE OCCURRED. THUS, NO FAILURE ANALYSIS HAS BEEN PERFORMED FOR THIS COMPLAINT.
Patient problems: Insufficient Information
MAUDE report 14324171 ↗MalfunctionApr 14, 2022Premature Separation; Premature Separation
A PATIENT UNDERWENT A 1 LEVEL SPINAL SURGERY FROM LEVEL L4-L5 ON (B)(6) 2021 CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM. SEASPINE WAS MADE AWARE THAT MULTIPLE SET SCREWS LOOSENED 2 MONTHS POSTOPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 14115647 ↗
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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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