Daytona 76-0030Recalls & reported problems

Seaspine Orthopedics Corporation · Ti Locking Cap Asm. 4.5mm, Small Stature · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10889981130619), received between Jun 2, 2021 and Sep 3, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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

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

Most reported problems

Device problems

Insufficient Device Problem Information3
Expulsion1

Patient problems

Insufficient Information3
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 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 3 OF 3 UNITS OF PART 76-0030, LOT MD15297D.
Patient problems: Insufficient Information
MAUDE report 20130657 ↗
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 3 UNITS OF PART 76-0030, LOT MD15297D.
Patient problems: Insufficient Information
MAUDE report 20130652 ↗
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 3 UNITS OF PART 76-0030, LOT MD15297D.
Patient problems: Insufficient Information
MAUDE report 20130651 ↗
MalfunctionJun 2, 2021Expulsion; Expulsion
IN (B)(6) OF 2020, A (B)(6) GIRL UNDERWENT T2-L2 PSIF SPINAL SURGERY WITH SEASPINE'S DAYTONA SMALL STATURE SPINAL SYSTEM, JAZZ SUBLAMINAR BANDS, AND SMALL STATURE CROSS CONNECTORS. IN A 2 WEEK POSTOPERATIVE FOLLOW UP, NO COMPLICATIONS WERE NOTED, HOWEVER IN THE 3 MONTH POSTOPERATIVE FOLLOW UP, THE SURGEON NOTICED A DISENGAGEMENT OF THE L2 RIGHT PEDICLE SCREW CAP, AND RECOMMENDED REVISION SURGERY. NO ADDITIONAL DETAILS REGARDING THE PATIENT'S CONDITION OR TREATMENT PLAN HAVE BEEN COMMUNICATED TO SEASPINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11926356 ↗

Device details

UDI-DI	`10889981130619`
Brand	Daytona
Model	76-0030
Company	Seaspine Orthopedics Corporation
Product code	NKB · Thoracolumbosacral pedicle screw system
Class	Class 2
FDA submission	K163604
Implant	Yes
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): Spinal bone set screw

A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

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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
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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