MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ASSY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112230
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the 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 or Problem Description
One of the medal ¿spokes¿ that viszadisc attaches broke off the pelvic array.Case type: tha.Update: "was the patient under anesthesia? yes.No involvement.Was there patient involvement? any patient harm? state any adverse consequences.No patient harm.No involvement".
Event or Problem Description
One of the medal ¿spokes¿ that viszadisc attaches broke off the pelvic array.Case type: tha.Update: "was the patient under anesthesia? yes.No involvement.Was there patient involvement? any patient harm? state any adverse consequences.No patient harm.No involvement".
Additional Manufacturer Narrative
One of the medal ¿spokes¿ that viszadisc attaches broke off the pelvic array.Case type: tha.Update: "was the patient under anesthesia? yes.No involvement.Was there patient involvement? any patient harm? state any adverse consequences.No patient harm.No involvement".Product evaluation and results: visual inspection: all metal post found on the pelvic array, see attached image.Product history review: review of the device history records indicate (b)(4) were manufactured under lot 19470117 and accepted into final stock on 04/07/2017.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112230, lot number 19470117 shows one additional complaints related to the failure in this investigation.Conclusions: the event was not confirmed, all metal post found on the pelvic array.

• Brand Name: PELVIC ARRAY ASSY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8995350
• Report Number: 3005985723-2019-00666
• Device Sequence Number: 3324041
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121064
• 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): 12/19/2019

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: Health Professional
• Device Catalogue Number: 112230
• Device Lot Number: 19470117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: Hospitalization