MAUDE Adverse Event Report: SYNTHES USA; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown date of event: unknown.This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown implant date: unknown date in 2003.Device has not been explanted yet; a revision procedure is scheduled but has not reportedly occurred.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient experienced malunion.The patient underwent a lefort 1 osteotomy in 2003.On an unknown date, the patient noticed that her maxilla moved when she chewed food.The patient initially opted not to undergo a revision procedure at that time.At a recent visit with the oral surgeon, the patient presented with jaw pain and headaches; movement to the right and left medial and posterior maxillary buttresses was noted where there are four implanted plates and screws.The surgeon diagnosed a malunion.Revision surgery is scheduled for the end of (b)(6) with anticipated hardware removal, bone debridement and new fixation.The reporter could not confirm if the patient was implanted with synthes devices.It was also noted that there may be possible hardware issues.This report is for an unknown plate.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

This report is for four unknown plates.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported the revision procedure that was scheduled for the end of (b)(6) has been rescheduled for the middle of (b)(6).This report is for four unknown plates.

Manufacturer Narrative

Product investigation was completed.Seven (7) plate pieces and fourteen (14) screws (part # 400.734) were returned to manufacturer for evaluation.The returned plate pieces were severely damaged in the form of twisting, cracking, and discolorations.It was reported that this damage was intentionally caused by the surgeon to aid in the removal of the implants.Due to the damage to the plates, the exact part numbers were not able to be identified.The screws are intact with only minor damage to the cruciform recesses.Drawing was reviewed for the screws and no anomalies were able to be identified.Aside from minor damage to the cruciform drive, the parts were conforming to specifications.A device history record review was unable to be performed far any of the implants since the lot numbers are unknown.The exact cause of the malunion could not be determined, but it was likely due to the patient chewing prior to adequate bone remodeling.This complaint is confirmed, but it was determined that it was not caused by the design of the implants.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update: on (b)(6) 2016 the patient underwent revision surgery for non-union.Hardware was intact at the time of removal and confirmed to be synthes devices.All hardware was removed: four (4) 1.5 l plates and fourteen (14) 1.5 millimeter (mm) titanium maxillofacial cortex screws.Two (2) of the plates had to be cut into pieces to be explanted which required an additional ten (10) to fifteen (15) minutes.The patient was revised with new synthes fixation and a bone graft taken from the hip.The procedure was successfully completed.The patient outcome was reported as stable.This report is for four (4) unknown plates.This is report 1 of 15 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5843940
• MDR Text Key: 51067701
• Report Number: 2520274-2016-13859
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 62