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

Model Number	VPT02A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via a field contact regarding a patient with an unknown indication for spinal therapy.It was reported that while pulling back on the curved needle from the cannula, the purple top attachment piece to the handle of the curved needle was broken.There were no patient complications as a result of this event.The product was discarded by the customer.(b)(6) 2020 e1a (hcp, rep): additional information was received from the field contact regarding, pre-operative diagnosis- vertebral compression fracture procedure- kyphoplasty the product came in contact with the patient.

• Brand Name: KYPHON KURVE CURVED BONE FILLER DEVICE
• 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: 10216555
• Report Number: 9612164-2020-02367
• Device Sequence Number: 16785453
• Product Code: LXH
• UDI-Device Identifier: 00763000026783
• UDI-Public: 00763000026783
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2020
• Device Model Number: VPT02A
• Device Catalogue Number: VPT02A
• Device Lot Number: 218519305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 59