MAUDE Adverse Event Report: SEASPINE, INC ALLOSYNC (TM) CB DBM PUTTY; ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY

Model Number	ABS-2014-10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on (b)(6) 2021, a patient had a surgery to remove the products implanted when an acl tunnel bone graft with dowels was discovered to have an infection in the area.The index surgery was (b)(6) 2021 and was a revision of a surgery performed years prior.The patient reported mild pain and swelling 1-week post op.The patient reported in the emergency room 3-weeks post op that the pain and swelling had increased.On (b)(6) 2021, it was determined that all products would be removed.The patient's current condition is not known.Review of labeling.Possible adverse effects: pain, discomfort, or abnormal sensations due to the presence of the device serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism, or death.
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.

• Brand Name: ALLOSYNC (TM) CB DBM PUTTY
• Common Device Name: ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 12250400
• Report Number: 3012120772-2021-00068
• Device Sequence Number: 14528343
• 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): 07/29/2021

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 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: 07/29/2021
• 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: Other; Required Intervention