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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE, INC DAYTONA SMALL STATURE SPINAL SYSTEM CONNECTOR SET SCREW, REPLACEMENT

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SEASPINE, INC DAYTONA SMALL STATURE SPINAL SYSTEM CONNECTOR SET SCREW, REPLACEMENT Back to Search Results
Model Number 76-0047
Device Problems Loose or Intermittent Connection (1371); Failure to Disconnect (2541)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2021
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the returned devices noted physical marks consistent with construct loosening. Evaluation of related torque-limiting devices noted testing on (b)(6) 2021 and (b)(6) 2021 in which these instruments were within established specifications. Review of labeling: possible adverse events: loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
 
Event Description
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.
 
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Brand NameDAYTONA SMALL STATURE SPINAL SYSTEM
Type of DeviceCONNECTOR SET SCREW, REPLACEMENT
Manufacturer (Section D)
SEASPINE, INC
5770 armada drive
carlsbad CA 92008
Manufacturer (Section G)
SEASPINE, INC
5770 armada drive
carlsbad CA 92008
Manufacturer Contact
amanda fonseca
5770 armada drive
carlsbad, CA 92008
MDR Report Key12380713
MDR Text Key268779954
Report Number3012120772-2021-00069
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10889981161293
UDI-Public10889981161293
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K200381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number76-0047
Device Catalogue Number76-0047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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