MAUDE Adverse Event Report: SEASPINE INC. REGATTA LATERAL SYSTEM; LATERAL IMPLANT, 23MM X 8MM X 45MM, 10 DEG

Model Number	36-230845-10
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Seaspine's regatta lateral system is intended for use with supplemental fixation.The index surgery on (b)(6) 2020 consisted of regatta implants as stand-alone devices without supplemental fixation; therefore, the devices were used off-label.The construct was revised on (b)(6) 2020 to reposition the implant and add supplemental posterior fixation consisting of seaspine's newport mis system.A review of labeling: indications for use the seaspine regatta lateral system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (ddd, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies).It 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.Surgical technique guide: supplemental fixation is required in conjunction with the regatta implant.
Event or Problem Description
On (b)(6) 2020, the patient underwent l3-l5 lateral lumbar interbody fusion (llif) surgery consisting of the regatta lateral system.On 11 jun 2020, seaspine was made aware of a postoperative implant migration at the l4/5 level.A revision surgery occurred on (b)(6) 2020 to reposition the implant and supplement with posterior fixation.

• Brand Name: REGATTA LATERAL SYSTEM
• Common Device Name: LATERAL IMPLANT, 23MM X 8MM X 45MM, 10 DEG
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• MDR Report Key: 10261317
• Report Number: 3012120772-2020-00053
• Device Sequence Number: 11699554
• Product Code: MAX
• UDI-Device Identifier: 10889981162108
• UDI-Public: 10889981162108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 36-230845-10
• Device Catalogue Number: 36-230845-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR