MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, THORACIC, RADIOLUCENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733148
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that, while outside of a procedure, the screw head of the adjustment screw for the spine clamp was stripped.There was no patient present when this issue was identified.No additional information was provided.
Additional Manufacturer Narrative
Correction: manufacturer updated to proper value.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLAMP, THORACIC, RADIOLUCENT
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7182566
• Report Number: 1723170-2018-00175
• Device Sequence Number: 135963
• Product Code: HAW
• UDI-Device Identifier: 00613994201263
• UDI-Public: 00613994201263
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K990214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2019

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
• Operator of Device: Physician
• Device Catalogue Number: 9733148
• Device Lot Number: 120928
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 04/21/2018; 04/21/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 04/21/2018; 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1