MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON KURVE BONE FILLER DEVICE 13GA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	VPT02A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Follow-up was made to (b)(6) health and received confirmation as below.Gender: female; date of birth: (b)(6).They confirmed that, information populated in medwatch report no: (b)(4) was incorrect i.E., gender and date of birth.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information received from initial reporter via medtronic field representative regarding an event happened during intra-op for a pre- operative diagnosis of osteoporosis.It was reported that the tip of needle broke inside cement bolus and was left inside patient.There were no patient symptoms reported as a result of this event.There were no complications to patient/physician were reported/anticipated.Additional information received on 27-aug-2020: it was mentioned that there is no revision surgery planned or scheduled as the broken tip was cemented in place.There were no patient complications reported as a result of this event.The therapy involved during this event was mentioned as kyphoplasty.

• Brand Name: KYPHON KURVE BONE FILLER DEVICE 13GA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10539986
• Report Number: 9612164-2020-03474
• Device Sequence Number: 11540676
• Product Code: LXH
• UDI-Device Identifier: 00763000026783
• UDI-Public: 00763000026783
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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 Expiration Date: 10/11/2020
• Device Model Number: VPT02A
• Device Catalogue Number: VPT02A
• Device Lot Number: 218655103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/16/2020
• 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: Other
• Patient Age: 81 YR