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

Model Number 36-231055-15

Device Problems Off-Label Use (1494); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted for lot# bs18g013a, and it was concluded that the products were inspected and accepted for use by the quality control department on 09/26/2018 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, it was confirmed via radiograph that the regatta lateral system was used off-label as it was not supplemented with fixation and was used in a three-level procedure although only approved for up to two-level contiguous usage, as indicated in the labeling.Additionally, it was reported that the patient did not follow post-operative care instructions and removed their brace prior to when instructed.Review of labeling notes: indications for use- the regatta lateral system is intended for use at either one level or two contiguous levels in the lumbar spine, from l2 to s1, for the treatment of ddd with up to grade 1 spondylolisthesis at the involved level(s).The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.The seaspine regatta lateral system is intended for use with supplemental fixation.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 Description

On (b)(6) 2019, the patient underwent a three-level lateral lumbar interbody fusion (llif) using the regatta lateral system.During a routine patient follow-up, x-rays were taken, and it was observed that the implant had migrated laterally but stayed contained within the disc space and an osteophyte.It was reported that post-operatively, the patient removed their brace prior to when instructed.Additionally, fixation was not used to supplement the interbody placement and is considered off-label use.At the time of contact, it was unknown if the surgeon will revise and patient was asymptomatic.No additional event information is available.

• Brand Name: REGATTA LATERAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: stephanie chavez ; 5770 armada drive; carlsbad, CA 92008 ; 7602165109
• MDR Report Key: 8504039
• MDR Text Key: 152802335
• Report Number: 3012120772-2019-00012
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10889981162153
• UDI-Public: 10889981162153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 36-231055-15
• Device Catalogue Number: 36-231055-15
• Device Lot Number: BS18G013A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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