MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC ACCELL CONNEXUS 1CC; BONE VOID FILLER,

Catalog Number	02-3000-010
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event could not be confirmed.No radiographs or mri were received.Graft material gave no indication of a product malfunction per the sales representative.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 4/12/2016 by the quality control department to ensure that they meet all specified parameters of the inspection report.No further evaluation of the product can be completed at this time.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.The root cause of this reported event has not been determined, no conclusion can be drawn.Device discarded by hospital.
Event or Problem Description
Initial acdf surgery at c5-c7 was performed on (b)(6) 2016.Osteophytes were removed to decompress site and autograph was mixed with 1 cc of allograft putty, and placed at the wound site.Event: on (b)(6) 2016 patient incurred pain and underwent revision surgery to remove part of the 1cc putty mixed with autonomous bone.It is believed that the graph was placed on or near the nerve, causing nerve irritation and patient pain.Patient outcome: post-revision surgery, the patient symptoms are expected to be relieved.

• Brand Name: ACCELL CONNEXUS 1CC
• Common Device Name: BONE VOID FILLER,
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 96218
• MDR Report Key: 6073859
• Report Number: 2090010-2016-00007
• Device Sequence Number: 18922488
• Product Code: MQV
• UDI-Device Identifier: 10889981055462
• UDI-Public: 10889981055462
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K061880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2016

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
• Operator of Device: Physician
• Device Expiration Date: 03/28/2017
• Device Catalogue Number: 02-3000-010
• Device Lot Number: 156013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 11/02/2016
• 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: 60 YR