Daytona Small StatureRecalls & reported problems across all models
Seaspine Orthopedics Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Daytona Small Stature model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 3 models of Daytona Small Stature by Seaspine Orthopedics Corporation in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Aug 27, 2021 and Sep 3, 2024 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
Daytona Small Stature recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 29, 2024Open, Classified
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Z-0752-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Oct 29, 2024Open, Classified
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Z-0751-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported Daytona Small Stature problems
Device problems
- Insufficient Device Problem Information13
- Failure to Disconnect1
- Loose or Intermittent Connection1
Patient problems
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions1
Daytona Small Stature models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Daytona® Small Stature 79-0002Thoracolumbosacral pedicle screw system1 recall13 reports
- Daytona® Small Stature 79-0001Appliance, fixation, spinal intervertebral body1 recall0 reports
- Daytona Small Stature 76-0047Thoracolumbosacral pedicle screw system1 report
Recent Daytona Small Stature adverse event reports
The 14 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 5 OF 5 UNITS OF PART 79-0002, LOT MM1002742E.
Patient problems: Insufficient Information
MAUDE report 20130654 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 4 OF 5 UNITS OF PART 79-0002, LOT MM1002742E.
Patient problems: Insufficient Information
MAUDE report 20130648 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 3 OF 5 UNITS OF PART 79-0002, LOT MM1002742E.
Patient problems: Insufficient Information
MAUDE report 20130647 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 2 OF 5 UNITS OF PART 79-0002, LOT MM1002742E.
Patient problems: Insufficient Information
MAUDE report 20130646 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 1 OF 5 UNITS OF PART 79-0002, LOT MM1002742E.
Patient problems: Insufficient Information
MAUDE report 20130641 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 7 OF 8 UNITS OF PART 79-0002, LOT MM1003065E.
Patient problems: Insufficient Information
MAUDE report 20130639 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 6 OF 8 UNITS OF PART 79-0002, LOT MM1003065E.
Patient problems: Insufficient Information
MAUDE report 20130638 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 8 OF 8 UNITS OF PART 79-0002, LOT MM1003065E.
Patient problems: Insufficient Information
MAUDE report 20130637 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 4 OF 8 UNITS OF PART 79-0002, LOT MM1003065E.
Patient problems: Insufficient Information
MAUDE report 20130633 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 5 OF 8 UNITS OF PART 79-0002, LOT MM1003065E.
Patient problems: Insufficient Information
MAUDE report 20130632 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 2 OF 8 UNITS OF PART 79-0002, LOT MM1003065E.
Patient problems: Insufficient Information
MAUDE report 20130631 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 1 OF 8 UNITS OF PART 79-0002, LOT MM1003065E.
Patient problems: Insufficient Information
MAUDE report 20130630 ↗MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM. DURING THE PROCEDURE THE SURGEON HAD ISSUES WITH THE LOCKING CAPS THREADING ONTO THE SCREWS, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. 13 UNITS OF PART 79-0002 AND 3 UNITS OF PART 76-0030 WERE RETURNED. SEE RELATED REPORTS. THIS REPORT IS FOR 3 OF 8 UNITS OF PART 79-0002, LOT MM1003065E.
Patient problems: Insufficient Information
MAUDE report 20130628 ↗MalfunctionAug 27, 2021Loose or Intermittent Connection; Failure to Disconnect; Loose or Intermittent Connection; Failure to Disconnect
USERS REPORTED THAT DURING A REVISION SURGERY TO REPOSITION THE PATIENT'S EXISTING GROWING ROD CONSTRUCT, INTRA-OPERATIVE MALFUNCTIONS OF THE MATERIALS WERE REPORTED. HOWEVER, SUBSEQUENT EVALUATION NOTED THE COMPONENTS HAD BEEN IMPLANTED IN THE FIRST SURGERY AND EXHIBITED SIGNS OF POST-OPERATIVE LOOSENING. BASED ON THE RESULS OF THE EVALUATION THE EVENT WAS DEEMED REPORTABLE WITH THE AWARENESS DATE OF (B)(6) 2021. THE LOOSENING WAS ASYMPTOMATIC AND WAS NOT NOTED DURING THE REVISION SURGERY. AVAILABLE INFORMATION SUGGESTS THAT THE GROWING ROD CONSTRUCT WAS INTENDED TO BE ADJUSTED AND COMPONENTS WERE NOT INTENDED TO BE REPLACED. HOWEVER, THE LOCK SCREW REPORTEDLY BECAME DEFORMED DURING THESE MANEUVERS AND COULD NOT BE REMOVED; THE ROD WAS CUT AND A ROD-ROD CONNECTOR WAS PLACED TO RE-CONNECT THE CONSTRUCT PORTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12380713 ↗
Other Seaspine Orthopedics Corporation products
- Mariner15 models · 147 reports · 1 recall
- Fathom3 models · 2 reports · 2 recalls
- NorthStar24 models · 15 reports · 1 recall
- Meridian8 models · 8 reports · 1 recall
- Mariner Deformity3 models · 2 reports · 1 recall
- Virata25 models · 0 reports · 1 recall
- Reef TA2 models · 0 reports · 1 recall
- Mariner RDX6 models · 0 reports · 1 recall
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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