MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC ACCELL EVO3C 5CC

Catalog Number 02-6000-050

Device Problems Collapse (1099); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 06/09/2015

Event Type  Injury  

Manufacturer Narrative

To device involved in the reported is not expected to be received for eval.An investigation has been initiated based upon the reported info.

Event Description

It was reported by the pt that he suffered pain following implantation of the devices.The pt underwent the initial procedure of spinal surgery (plif fusion with s1 lift in the l5 of the spine) on (b)(6) 2014.He visited the operating surgeon two months postoperatively complaining of pain.The pt states no diagnostic procedures or treatment were rendered.Following this visit the surgeon left his practice located in (b)(6), without notice.Four months postoperatively the pt reports his condition worsened.He went to a different physician for pain management.His condition continued to worsen.He obtained a new physician.X-rays and mri's were done.He was scheduled for more surgery.On (b)(6) 2015 the pt underwent a revision procedure.The pt states his surgeon reported when he opened him up he found that the "cage" as collapsing.The pt was told the cages were too small and the screws and other hardware were too small and "all wrong".The surgeon said, "they were empty", implying there was no bone.New hardware, etc.Were implanted.The pt reports experiencing immediate relief.He is (now) up and walking and is pain free.The pt reports he lost nine months of his life because of the initial surgeon.After review the pt discovered there were products used for the initial surgery from at least two other mfrs- including titan spine.Although the pt believed an integra representative was present for the initial surgery ("female whose name begins with "(b)(6)"), the integra representative for this customer/surgeon is a male who reports he was not present at this operation.The integra representative stated he did a small amount of business with the initial surgeon but that has stopped since the surgeon's departure (from (b)(6)).

Manufacturer Narrative

Integra completed its internal investigation 26jan2016.The investigation included: method: review of device history records.Review of complaint management database for similar complaints.Results: a dhr review cannot be performed at this time as the lot number was not provided and the device wasn't returned for evaluation.Complaint history since 2012 was reviewed.(b)(4).Conclusion: root cause could not be established.

• Brand Name: ACCELL EVO3C 5CC
• Type of Device: ACCELL
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 92618
• Manufacturer (Section G): ISOTIS ORTHOBIOLOGICS, INC; 2 goodyear place, suite a; irvine CA 96218
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5020618
• MDR Text Key: 23907278
• Report Number: 2090010-2015-00036
• Device Sequence Number: 1
• Product Code: MQV
• 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: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02-6000-050
• Device Lot Number: 1411104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR