MAUDE Adverse Event Report: SYNTHES USA; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Baumann a., sinko k., and dorner g.(2015) late reconstruction of the orbit with patient-specific implants using computer-aided planning and navigation.J oral maxillofac surg 73:s101-s106.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received: this report is being filed after the subsequent review of the following literature article: baumann a., sinko k., and dorner g.(2015) late reconstruction of the orbit with patient-specific implants using computer-aided planning and navigation.J oral maxillofac surg 73:s101-s106.A retrospective study was performed of patients who underwent late orbital reconstruction from 2009 to 2013.To be included in the study, patients had a unilateral orbital deformity by involvement of at least two orbital wall defects.Six patients were included in this study (5 men and 1 woman) with a mean age of 34.7 years (range, 20 to 62 yr).A poly-ether-ether-ketone (peek) implant was used in 4 cases.Two patients received a titanium mesh psi (patient-specific implants).The data of the reconstructed orbit with the determination of the planned psi were sent to the manufacturer (depuy synthes, (b)(4); or kls martin, (b)(4)).Complications were seen in the patient with tumor, a skin perforation of the solid titanium psi in the nasal region was seen 3 months after placement.The exposed implant was reduced and covered with local soft tissue.Afterward, no more complications were seen in this patient.It cannot be determined which patients were implanted with depuy synthes or kls martin devices.This report is for unknown peek implants and unknown solid titanium psis.

• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6250451
• MDR Text Key: 64906015
• Report Number: 2520274-2017-10146
• Device Sequence Number: 1
• Product Code: GXN
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention