MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS INC. ARTHREX; ALLOSYNC CB DBM PUTTY, 10CC VIAL

Model Number	ABS-2014-10
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2021, it was documented that a surgical procedure took place to extract implanted materials following the identification of an infection in the area related to an acl tunnel bone graft with dowels.The initial surgery occurred on (b)(6) 2021, serving as a revision to a previous operation conducted years ago.The patient initially experienced mild pain and swelling one week after the operation.However, three weeks post-operation, the patient presented to the emergency room reporting an escalation in pain and swelling.Subsequently, on (b)(6) 2021, a decision was made to remove all implanted products.The current status of the patient's condition remains undisclosed.Review of labeling.Potential adverse events: superficial wound infection, deep wound infection with or without osteomyelitis.
Event or Problem Description
On (b)(6) 2021, an acl tunnel bone graft with dowels procedure was performed.The procedure was the 1st stage revision of a surgery that occurred several years prior.On (b)(6) 2021 at a follow up, the patient complained of mild pain and moderate swelling.On (b)(6) 2021, the patient was seen in an emergency room reporting increased swelling and pain.On (b)(6) 2021, the patient followed up with their provider and was diagnosed with an infection.It was determined that all the items implanted would need to be removed, including the abs-2014-10 allosync cb dbm putty, 10cc and 2 dowels.The dowels are not arthrex items.The events described above were previously inaccurately reported through report number 3012120772-2021-00068.This report is issued to rectify this mistake and substitute the prior report filed under the incorrect registry.

• Brand Name: ARTHREX
• Common Device Name: ALLOSYNC CB DBM PUTTY, 10CC VIAL
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS INC.; 2 goodyear, suite a; irvine CA 92618
• Manufacturer (Section G): ISOTIS ORTHOBIOLOGICS INC.; 2 goodyear, suite a; irvine CA 92618
• Manufacturer Contact: audrey mudderman ; 2 goodyear, suite a; irvine, CA 92618
• MDR Report Key: 18455850
• Report Number: 3001503333-2024-00001
• Device Sequence Number: 15223706
• Product Code: MQV
• UDI-Device Identifier: 10889981153694
• UDI-Public: 10889981153694
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: ABS-2014-10
• Device Catalogue Number: ABS-2014-10
• Device Lot Number: 172787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON ISOTIS DOWELS
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown