MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NEURAY® PACKING; NEUROSURGICAL PADDIE

Model Number 8004000

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: analysis results are not available; device not returned for evaluation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The surgeon reported that during an olif spinal surgery "the string [of the neuray pattie] was cut by the bur" when cutting bone.The surgeon believes that "all the string was taken out from the patient"; he was unsure if the pattie still remains along the spine.It was confirmed that both irrigation and suction were being used during the procedure, and it is possible that the pattie and the string were both removed by the suction.There were no interventions performed to locate the device(s) and no procedures or treatments are planned.At this time the patient's condition is "normal".

Manufacturer Narrative

Corrected information: sex, no eval explain code.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEURAY® PACKING
• Type of Device: NEUROSURGICAL PADDIE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 6647165
• MDR Text Key: 77772769
• Report Number: 1045254-2017-00195
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K923027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8004000
• Device Catalogue Number: 8004000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR