Daytona® Small Stature 79-0002Recalls & reported problems

Seaspine Orthopedics Corporation · CoCr Locking Cap 4.5mm, Small Stature, T25, BT · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 13
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10889981185640), received between Sep 3, 2024 and Sep 3, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 reports).

1 FDA recall record name this device's identifier, 1 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, 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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Oct 29, 2024Class IIOpen, 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 problems

Device problems

Insufficient Device Problem Information13

Patient problems

Insufficient Information13

Recent adverse event reports

The 13 most recent of 13 reports, 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 ↗

Device details

UDI-DI	`10889981185640`
Brand	Daytona® Small Stature
Model	79-0002
Company	Seaspine Orthopedics Corporation
Product code	NKB · Thoracolumbosacral pedicle screw system
Class	Class 2
FDA submission	K200381
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 24, 2025

Device type (GMDN): Bone-screw internal spinal fixation system, non-sterile

An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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All Thoracolumbosacral pedicle screw system devices →

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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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