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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); No Code Available (3191)

Event Date 11/05/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown ¿ 2.0 mm titanium screws and unknown ¿ 2.0 mm bicortical screws/unknown quantity/unknown lot.(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following literature article stoor, p., suomalainen, a., mesimaki, k.And kontio, r.(2017) rapid prototyped patient specific guiding implants in critical mandibular reconstruction.Journal of cranio-maxillo-facial surgery, volume 45: 63-70.The aim of this study was to assess if a clinically usable patient specific mandibular implant with the right anatomic shape can be manufactured utilizing computer aided design (cad) - computer aided manufacturing (cam) technique.The second aim was to study if the implant could be designed in such a way that it guides without navigation the surgeon to place the implant in the operative theatre similarly to the cad design.This prospective study was performed with 14 patients with a total of 15 patient specific implants (psis).There were a total of ten (10) males and four (4) females with an average age of 63 years (39-77 years).Follow-up period was on average 33 months (6-49 months).This is report 1 of 6 for (b)(4) this report is for an unknown ¿ 2.0 mm titanium screws and unknown ¿ 2.0 mm bicortical screws and refers to patient 1 (female, (b)(6) who had perforation of lingual mucosa due to the rp-implant being too high at that region.After revision and shortening of the lingual implant foil the healing was uneventful.Patient also experienced strong chronic inflammation.

• Type of Device: SCREW, FIXATION, BONE
• 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: 6800196
• MDR Text Key: 82896145
• Report Number: 2520274-2017-12102
• Device Sequence Number: 1
• Product Code: HWC
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/17/2017
• 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
• Patient Age: 66 YR