MAUDE Adverse Event Report: SEASPINE INC. PEDICLE PROBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Lot Number S2389

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2016

Event Type  malfunction  

Event Description

During a spinal surgery, the surgeon was using the pedicle probe when the tip sheared off inside the surgical wound - all pieces were successfully removed from the surgical wound.No harm to the patient.

Manufacturer Narrative

The following elements have blank data: unique device identifier (udi): for type of device: orthopedic manual surgical instrument.

Event Description

During a spinal surgery, the surgeon was using the pedicle probe when the tip sheared off inside the surgical wound - all pieces were successful removed form the surgical wound.No harm to the patient.

• Brand Name: PEDICLE PROBE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SEASPINE INC.; 2302 la mirada dr.; vista CA 92081
• MDR Report Key: 5837110
• MDR Text Key: 50885333
• Report Number: 5837110
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

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
• Device Operator: Physician
• Device Lot Number: S2389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2016
• Event Location: Other
• Date Report to Manufacturer: 07/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR