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

Model Number	76-0047
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CONNECTOR SET SCREW, REPLACEMENT
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 12380713
• Report Number: 3012120772-2021-00069
• Device Sequence Number: 11896237
• Product Code: NKB
• UDI-Device Identifier: 10889981161293
• UDI-Public: 10889981161293
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K200381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1