MAUDE Adverse Event Report: MAZOR ROBOTICS LTD. RENAISSANCE SYSTEM; STEREOTAXIC INSTRUMENT

Model Number	TPL0038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Spinal Column Injury (2081)
Date of Event	11/02/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The data was gathered as part of an ongoing prospective clinical study (pmcf): mis refresh, available on clinicaltrials.Gov: https://clinicaltrials.Gov/ct2/show/study/nct02057744?term=mis+refresh&rank=1#contacts.These adverse events are being submitted shortly after the company completed an internal retrospective review process of historic records.
Event or Problem Description
According to data that was gathered as part of an ongoing prospective clinical study (pmcf), three adverse events were reported with the following issues: one patient suffered from right lower extremity radiculopathy.A revision surgery was performed.One patient suffered from left foot drop, requiring conservative treatment and/or medication.One patient suffered from pseudoarthrosis.Only the second event resulted in a permanent damage or disability.The two other events were resolved.

• Brand Name: RENAISSANCE SYSTEM
• Common Device Name: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; pob 3140, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• MDR Report Key: 7988292
• Report Number: 3005075696-2018-00026
• Device Sequence Number: 13799543
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K120812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2015
• Initial Report FDA Received Date: 10/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability