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

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.

• Brand Name: DAYTONA SMALL STATURE SPINAL SYSTEM
• Type of Device: CONNECTOR 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 Key: 12380713
• MDR Text Key: 268779954
• Report Number: 3012120772-2021-00069
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981161293
• UDI-Public: 10889981161293
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K200381
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 76-0047
• Device Catalogue Number: 76-0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1