MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AVAFLEX CN KIT W/O NEEDLE; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Model Number	1025011500
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not available for return.
Event or Problem Description
It was reported that the cement hardened too quickly around the needle which interfered with the removal of the needle.The physician made an incision to cut down the needle.There was no additional adverse consequences reported and no clinically significant medical delay.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.Device unavailable for return - discarded.
Event or Problem Description
It was reported that the cement hardened too quickly around the needle which interfered with the removal of the needle.The physician made an incision to cut down the needle.There was no additional adverse consequences reported and no clinically significant medical delay.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.
Event or Problem Description
It was reported that the cement hardened too quickly around the needle which interfered with the removal of the needle.The physician made an incision to cut down the needle.There was no additional adverse consequences reported and no clinically significant medical delay.It was further reported that the procedure was completed successfully.

• Brand Name: AVAFLEX CN KIT W/O NEEDLE
• Common Device Name: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9985656
• Report Number: 0001811755-2020-00936
• Device Sequence Number: 4442663
• Product Code: OAR
• UDI-Device Identifier: 07613327374629
• UDI-Public: 07613327374629
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2020

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: 1025011500
• Device Catalogue Number: 1025011500
• Device Lot Number: 5991086
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 03/26/2020; 11/28/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 04/29/2020; 12/01/2020
• 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