MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC ORTHOBLAST-II PASTE ; ORTHOBLAST

Catalog Number 02-2100-010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Osteolysis (2377); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

It was reported that following an interbody fusion surgery osteolysis was found.The product was removed when osteolysis was found.It was reported the current opinion is the problem is not because of the orthoblast product.The pt was elderly, over 70 years old, and had combined orthopedic surgery (posterolateral fusion, interbody fusion with bone substitute).Add'l info has been requested.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Integra has completed their internal investigation on 07/13/2015.Methods, review of device history records, review of complaint history - results: no product samples, nor support documentation, were retuned to the manufacturer.No product was retuned to the manufacturer.Additionally, the lot number of the product was not confirmed.The orthoblast 11 paste product is suspected to be manufactured under lot number 141899.The complete device history record was reviewed and no anomalies were noted.The product was manufactured and released in accordance with product specifications.The demineralization record for the demineralized bone used in lot number 141899 was reviewed and no anomalies were noted.The applicable donor files were reviewed and no anomalies were noted.All donors are prescreened by a medical director at our tissue bank for serology and microbial cultures.A retain sample was reviewed and no anomalies were detected.The complaint database was reviewed for the last two years and such review indicated there were no other related complaints for this product.Conclusion: no product was returned to the manufacturer.Additionally, the lot number of the product was not confirmed.The orthoblast il paste product is "suspected" to be manufactured under lot number 141899.The complete device history record was reviewed and no anomalies were noted.The product was not used as intended osteolysis cannot be determined in such a short time period in accordance with the directions for use which states "sites grafted with orthoblast 11 should be allowed to heal approximately 6 months prior to implant placement." resultantly, no root cause could be determined.

• Brand Name: ORTHOBLAST-II PASTE
• Type of Device: ORTHOBLAST
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 92618
• Manufacturer Contact: maria leonard ; 311 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4691853
• MDR Text Key: 5650110
• Report Number: 2090010-2015-00006
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K050642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02-2100-010
• Device Lot Number: 141899 (SUSPECTED LOT)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention