MAUDE Adverse Event Report: SEASPINE INC. ACCELL EVO3C

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

Treatment description: removal of posterior segmental instrumentation l2-s1, posterior arthrodesis l5-s1 and s1 to ilium with bone morphogenic protein and allograft, new posterior segmental instrumentation l2-ilium.Outcome: improvement in patient posture and sagittal balance.Review of labeling: indications for use accell evo3® is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure.The product is indicated for use as a bone graft extender in the spine, extremities and pelvis.Accell evo3 may also be used as a bone void filler in the posterolateral spine, extremities and pelvis.The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.Description accell evo3 is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium.Accell evo3 is formulated into a putty form and is provided in a sterile, single use package.As a biological material, some variations in the product should be expected, such as in appearance and handling.Postoperative care postoperative patient management should follow the same regimen as similar cases utilizing autogenous bone grafting.Standard postoperative practices should be followed, particularly as applicable to defect repairs involving the use of fixation devices.The patient should be cautioned against early weight bearing and premature ambulation that could lead to loosening and/or failure of the fixators or loss of reduction.The length of time a defect should remain in a reduced state of loading is determined by the complexity of the defect site and the overall physical condition of the patient.Hardware should not be removed until the defect is healed.Potential adverse events: surgical procedures involving implantation of bone grafts are associated with the following risks: superficial wound infection, deep wound infection with or without osteomyelitis, nonunion, delayed union and/or malunion, wound dehiscence, loss of reduction, refracture, cyst recurrence, hematoma, cellulitis.

Event Description

The patient underwent spinal surgery on (b)(6) 2017, which consisted of posterior fixation using nuvasive's reline system, an unknown implant cage manufactured by america, and seaspine's accell evo3 demineralized bone matrix.Seaspine was made aware on 10 jul 2020 of the loosening of the s1 screws, fracture through the sacral segment, and pseudarthrosis across the l5-s1 level.

• Brand Name: ACCELL EVO3C
• Type of Device: ACCELL EVO3C
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer (Section G): ISOTIS ORTHOBIOLOGICS INC.; 2 goodyear, suite a; irvine, ca
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, ca ; 2165137
• MDR Report Key: 10380241
• MDR Text Key: 207897567
• Report Number: 3012120772-2020-00054
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2020
• 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
• Patient Outcome(s): Required Intervention