MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP 9734715 SPINOUS PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734715

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problem Spinal Column Injury (2081)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).The spinous clamp was not returned to the manufacturer; therefore there was no evaluation conducted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a cervical spine procedure.The issue occurred intraoperatively and delayed the surgery by 20 minutes.It was reported that the site was going to do a posterior cervical fusion c1-c3.They put the long spinous process clamp on c2 but couldn't get the clamp to close, the surgeon had to remove bone in order to get the clamp to close.The surgeon tried to get the clamp tightened which ended up crushing the spinous process then it broke off.The surgeon tried the same thing on c3 and he removed bone to get it to tighten but then he tightened it and it crushed the spinous process then broke off.The surgeon used a second long spinous process clamp but couldn't get any purchase on it.The manufacturer representative (mr) then tried locating a 3rd spinous process clamp to try but the time he got back, the site ended up aborting navigation.The mr looked at both clamps and they appeared to function as expected.

• Brand Name: CLAMP 9734715 SPINOUS PROCESS TALL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7908075
• MDR Text Key: 121700662
• Report Number: 1723170-2018-04919
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9734715
• Device Catalogue Number: 9734715
• Device Lot Number: 170425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 85