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

Model Number RA1-211210

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/15/2021

Event Type  Injury  

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 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
• Type of Device: NO-PROFILE INTERBODY, 325 X 27 X 12 MM, 10 DEGREES
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: macy nicol ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 11675881
• MDR Text Key: 245848800
• Report Number: 3012120772-2021-00030
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10889981215361
• UDI-Public: 10889981215361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200879
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RA1-211210
• Device Catalogue Number: RA1-211210
• Device Lot Number: EL2004025D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR