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

Model Number	9734716
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/19/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while outside of a procedure, the spine clamp was reported to be damaged.There was no patient present when this issue was identified.No additional information was provided.
Additional Manufacturer Narrative
Medtronic received information that the retainer ring of the clamp was damaged.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHORT SPINOUS PROCESS CLAMP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7995407
• Report Number: 1723170-2018-05295
• Device Sequence Number: 1255247
• Product Code: OLO
• UDI-Device Identifier: 00643169936294
• UDI-Public: 00643169936294
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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: No Information
• Device Model Number: 9734716
• Device Catalogue Number: 9734716
• Device Lot Number: 160318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1