MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC OSTEOSURGE 300 -ACCELL EVO3 FAMILY; BONE VOID FILLER, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Catalog Number 56500100

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

Event could not be confirmed.No radiographs or mri were received.Photos of the first partial explant of graft material gave no indication of a product malfunction.The explant did not look to be in a gelatin state in the photo.The bone void filler graft is a reverse phase material that has a putty consistency.When bone void filler is being mixed with autograft, a ratio of 1:1 should be used.It does not require rehydration prior to use.The addition of bma and heparin at a ratio other than 1:1 in this case may have affected its consistency.No product will be returned as it was discarded by the hospital.Dhr review concluded that the product was manufactured, inspected and accepted for use on 3/25/2016 by the quality control department to ensure that they meet all specified parameters of the inspection report.Second revision was performed to remove the remaining graft.This explant was also not returned.No further evaluation of the product can be completed at this time.Review of historical complaints, notes no similar complaints of this nature have been reported for this product line.Patient's bone quality is unknown.Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all planes.The degree of spinal instability is unknown.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.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.Though neuromonitoring was used, it is unknown if the globus screws have caused or contributed to the neuro deficit (no known pedicle screw breach has been reported intra-operatively or post operatively.) the root cause of this reported event has not been determined, no conclusion can be drawn.Discarded by hospital.

Event Description

Initial plf surgery on (b)(6) 2016 to address left leg pain, involved direct decompression of the thecal sac, placement of globus pedicle screw system construct from l4 to s1, and posterolateral gutter fusion consisting of bmac (bone marrow aspirate concentrate) mixed with heparin and bone void filler putty placed in the lateral gutters.Patient was asymptomatic and walking immediate post-operatively.Event: third day post-operatively the patient had pain and numbness in the right leg.Upon evaluation of the mri it was determined that the thecal sac was compressed by a possible hematoma/ seroma (possible cause of the neurological deficit.) during revision, no hematoma was found, but inflammation of the area was observed and graft was observed to have a gelatin consistency and near the nerve.Revision was performed removing 50% of the posterolateral fusion material near the thecal sac.On the fifth day an additional mri scan was performed and it depicted a reoccurring seroma in the same area.Patient outcome: patient current having leg pain in both legs and numbness in the feet, post revision.Surgeon is evaluating patient and a second revision was planned for (b)(6) 2016.

• Brand Name: OSTEOSURGE 300 -ACCELL EVO3 FAMILY
• Type of Device: BONE VOID FILLER, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 96218
• Manufacturer Contact: peter perhach ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165681
• MDR Report Key: 5835393
• MDR Text Key: 50817891
• Report Number: 2090010-2016-00006
• Device Sequence Number: 1
• Product Code: MBP
• UDI-Device Identifier: 10889981055851
• UDI-Public: 10889981055851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2016

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
• Device Operator: Physician
• Device Expiration Date: 03/28/2017
• Device Catalogue Number: 56500100
• Device Lot Number: 156067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2016
• 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
• Patient Age: 44 YR