MAUDE Adverse Event Report: SEASPINE INC. REGATTA LATERAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	36-230855-10
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for lot: bs18g009a, and it was concluded that the products were inspected and accepted for use by the quality control department on 08/29/2018 and met all specified parameters of the receiving inspection report (rir) with no associated nonconformances.At the time of this report, the device remains implanted and is not available for evaluation.However, a radiograph was provided, which showed the lateral migration of the implant.The reported allegation of post-operative implant migration was confirmed.A root cause was unable to be determined however, through additional discussion with the performing surgeon it was determined that the surgical technique may have been a contributing factor to implant migration.Review of labeling notes: postoperative warnings- surgeons should advise patients regarding the risks of surgery and the importance of post-operative compliance.The patient should be advised to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation.The patient should be advised that implants may bend, break or loosen despite restriction in activity.Possible adverse events: delayed union or non-union (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.Bending, disassembly or fracture of implant and components.
Event or Problem Description
On (b)(6) 2019, the patient underwent a one-level lateral lumbar interbody fusion (llif) using the regatta lateral system supplemented with unilateral screws.During a routine patient follow-up, x-rays were taken, and it was observed that the implant had migrated out of the disc space.At the time of last contact, patient was asymptomatic, and the surgeon did not plan to revise but would continue to monitor.No additional event information is available.

• Brand Name: REGATTA LATERAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 8505573
• Report Number: 3012120772-2019-00013
• Device Sequence Number: 16192575
• Product Code: MAX
• UDI-Device Identifier: 10889981162146
• UDI-Public: 10889981162146
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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: 36-230855-10
• Device Catalogue Number: 36-230855-10
• Device Lot Number: BS18G013A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1