MAUDE Adverse Event Report: SEASPINE, INC SHORELINE¿ ACS; 7MM, LOCKING COVER

Model Number 85-2107

Device Problems Migration or Expulsion of Device (1395); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

This event was initially reported on 3012120772-2023-00009.This report is being submitted to provide the information of the 85-2107 7mm, locking cover involved in the event.The contributors to the root cause are as follows: the failure on the locking cover side was likely caused by the stripped threads on the spacer, which prevented the locking cover from achieving proper engagement after fixation. on the screw portion of the failure, the loss of bone integrity from the re-trajectory at that screw location would have contributed to the difficulty.  first, like the stripped threads on the spacer, create a situation that would prevent the screw from achieving the optimal tapping/threading into the bone. also, the lack of overall height available in the collapsed vertebral body limits the choices available for both screw depth & angulation during fixation into the vertebral body.Review of labeling (ifu): possible adverse events: like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis).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.Loss of proper spinal curvature, correction, height, and/or reduction.Postoperative fracture due to trauma, defects, or poor bone stock.

Event Description

This event was initially reported on 3012120772-2023-00009.This report is being submitted to provide the information of the 85-2107 7mm, locking cover involved in the event.Seaspine was made aware on 03 april 2023 that a patient underwent spinal surgery consisting of seaspine' s shoreline system.The index surgery took place on (b)(6) 2022.The x-ray provided appears to show that a screw loosened post-operatively.On 11 april 2023 the reporter noted that at the 3-month checkup, the screw had started to back out already as observed on a lateral x-ray.At a subsequent checkup about a month ago the surgeon observed that the screw had become completely disassociated with the rest of the construct.The reporter added that the construct span from c5-c7.The c5 and c6 vertebral bodies both appear to have some collapse to them.They appear to be much shorter in height than the adjacent levels, making them wonder about bone quality.Also, during the procedure the resident took a trajectory into c6 that dr.Lennarson didn't like so he revised a couple of screws during the index procedure.A revision surgery then took place on (b)(6) 2023.

• Brand Name: SHORELINE¿ ACS
• Type of Device: 7MM, LOCKING COVER
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: robin quiusky ; 5770 armada drive; carlsbad
• MDR Report Key: 17623442
• MDR Text Key: 321945263
• Report Number: 3012120772-2023-00026
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 10889981125080
• UDI-Public: 10889981125080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201646
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85-2107
• Device Catalogue Number: 85-2107
• Device Lot Number: MK63061B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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
• Treatment: 3-HOLE PLATE, LOCKING COVER, INTERBODY, SCREWS
• Patient Outcome(s): Required Intervention