MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON V OSTEO INTRODUCER 11GA BEVEL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	VPT11B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/01/2018
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
It was reported that the patient underwent vertebroplasty surgery due to some unspecified reasons.Intra-op, while filling of cement into the patients vertebra the doctor could not remove the needle from the patient.The handle broke off from the cannula leaving the tubular metal stuck in the patients vertebral body.The doctor attempted to remove with vice grips but the metal just broke apart.Doctor then cut down the metal to below the skin and the patient sent to the operation room.In the operation room they tried removing the needle but it would not budge so they proceeded to cut it down and leave it within the pedicle of the vertebral body.

• Brand Name: KYPHON V OSTEO INTRODUCER 11GA BEVEL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7298770
• Report Number: 1030489-2018-00282
• Device Sequence Number: 957841
• Product Code: LXH
• UDI-Device Identifier: 00643169637450
• UDI-Public: 00643169637450
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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): 02/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VPT11B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/27/2018
• 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