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

Catalog Number 112230

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

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 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 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".

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
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8995350
• MDR Text Key: 158161881
• Report Number: 3005985723-2019-00666
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486002923
• UDI-Public: 00848486002923
• Combination Product (y/n): N
• PMA/PMN Number: K121064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization