MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHOPAK TRAY; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	KPT1502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-op diagnosis: primary osteoporosis levels implant: t12 it was reported that intra-op, while performing pedicle approach to the left of t12 of the patient and trying to enter the bone access needle using bone access needle, it pricked the tip of the left forefinger of the surgeon and the surgeon doctor got injured.The product did not contact with the patient.No patient complications were reported as a result of the event.

• Brand Name: KYPHOPAK TRAY
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel ; CH
• MDR Report Key: 7788229
• Report Number: 2953769-2018-00022
• Device Sequence Number: 14065186
• Product Code: HRX
• UDI-Device Identifier: 00858196001512
• UDI-Public: 00858196001512
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: KPT1502
• Device Lot Number: 0009073180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/16/2018
• 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