MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MERIDIAN; NO-PROFILE INTERBODY, 325 X 27 X 12 MM, 10 DEGREES

Model Number	RA1-211210
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Seaspine became aware of this event on 19 mar 2021.No device was made available for investigation as the implant remains in situ.No additional details about the patient's condition have been reported to seaspine.Review of labeling: possible adverse events: improper surgical placement of the implant causing stress shielding of the graft or fusion mass.Serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, paralysis or death.
Event or Problem Description
On (b)(6) 2021, the patient underwent single-level (l5-s1) alif spinal surgery consisting of seaspine's meridian system.During the surgery, the surgeon attempted to place a stand-alone, no- profile interbody, which featured two downward anchors and one upward screw.The surgeon determined the placement was not ideal, and attempted to remove the anchor to allow for repositioning, creating a bone void during the removal process.The bone void was too large to accommodate any type of fixation in that location, so the surgeon completed the case by placing one downward screw.The final construct consisted of a three-hole stand-alone, no-profile interbody fixated by one upward screw and one downward screw, with a void at the third hole.

• Brand Name: MERIDIAN
• Common Device Name: NO-PROFILE INTERBODY, 325 X 27 X 12 MM, 10 DEGREES
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 11675881
• Report Number: 3012120772-2021-00030
• Device Sequence Number: 11537587
• Product Code: MAX
• UDI-Device Identifier: 10889981215361
• UDI-Public: 10889981215361
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/15/2021

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: No Information
• Device Expiration Date: 09/15/2025
• Device Model Number: RA1-211210
• Device Catalogue Number: RA1-211210
• Device Lot Number: EL2004025D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/15/2021
• 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: Other
• Patient Age: 83 YR