MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Model Number 209999

Device Problems Computer Software Problem (1112); Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 11/25/2018

Event Type  Injury  

Manufacturer Narrative

¿as part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.¿.

Event Description

The patient gave the informed consent for the mako - unicompartmental knee system test on (b)(6) 2018 (screening number: (b)(4)).On november 19, 2018, the patient was enrolled in the trial (random number: (b)(4)).At present, the patient is in the recovery stage on the eighth day after surgery.On (b)(6) 2018, the results of blood test dated on (b)(6) 2015 was reported: c-reactive protein 38.95ml / l, slight redness around the surgical incision, and slightly higher skin temperature compared with the contralateral side.The possibility of surgical incision infection was considered.

Manufacturer Narrative

Reported event: an event regarding other involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the device history records could not be performed as the robot serial number was not reported.Complaint history: a search of the complaint database under device identification pn 209999 reports similar complaints for pka software - other.The complaint record numbers are: (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4).Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including session data, operative reports, progress notes, pathology reports, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Corrective action/preventive action: a search of the nc/capa database under device identification pn 209999 reports no records related to pka software - other.

Event Description

Please find attachment for more information.The patient gave the informed consent for the mako - unicompartmental knee system test on (b)(6) 2018 (screening number: (b)(6)).On (b)(6) 2018, the patient was enrolled in the trial (random number: (b)(6)).At present, the patient is in the recovery stage on the eighth day after surgery.On 2018-11-27, the results of blood test dated on (b)(6) 2015 was reported: c-reactive protein 38.95ml / l, slight redness around the surgical incision, and slightly higher skin temperature compared with the contralateral side.The possibility of surgical incision infection was considered.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8161729
• MDR Text Key: 130254210
• Report Number: 3005985723-2018-00744
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 69