MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AFB1120-AVAFLEX BALLOON11G 20MM; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Model Number	1031120000
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the curved injection needle became stuck in the patient's back.Medical intervention was necessary as it was reported that the physicians had to dissect to the bone and cut off the needle flush at the bone leaving the portion that was stuck in the patient's body.The remainder of the needle was left behind in the patient.No further adverse consequences were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that the curved injection needle became stuck in the patient's back.Medical intervention was necessary as it was reported that the physicians had to dissect to the bone and cut off the needle flush at the bone leaving the portion that was stuck in the patient's body.The remainder of the needle was left behind in the patient.No further adverse consequences were reported.
Event or Problem Description
It was reported that the curved injection needle became stuck in the patient's back.Medical intervention was necessary as it was reported that the physicians had to dissect to the bone and cut off the needle flush at the bone leaving the portion that was stuck in the patient's body.The remainder of the needle was left behind in the patient.No further adverse consequences were reported.
Additional Manufacturer Narrative
Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.

• Brand Name: AFB1120-AVAFLEX BALLOON11G 20MM
• 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: 8934608
• Report Number: 0001811755-2019-02823
• Device Sequence Number: 10916979
• Product Code: OAR
• UDI-Device Identifier: 07613327374582
• UDI-Public: 07613327374582
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/30/2020

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: 1031120000
• Device Catalogue Number: 1031120000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 07/30/2019; 11/28/2020
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 04/06/2020; 11/30/2020
• 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