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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 04/07/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of event: wilde, f., et al.(2015).Multicenter study on the use of patient-specific cad/cam reconstruction plates for mandibular reconstruction.Int j.Cars 10:2035-2051.Germany.This report is for an unknown-screw/unknown quantity/unknown lot; udi: unknown part number, udi is unavailable.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

Literature article received.This report is being filed after the subsequent review of the following literature article."multicenter study on the use of patient-specific cad/cam reconstruction plates for mandibular reconstruction" wilde, f., et al.(2015).Int j.Cars 10:2035-2051.Study conducted in germany.A multicenter study was conducted to focus on patient specific mandibular plates (psmps) that were planned for mandibular reconstruction in 32 patients between february 2013 and may 2014.Patients requiring mandibular reconstruction were included in the study.Preparation for planning process was obtained via dicom data of preoperative computed tomography (ct) scans required for reconstruction planning were transferred through trumatch cmf solution proplan cmf.The indications and types of mandibular reconstructions with a psmp are as follows: mandibular reconstruction was indicated by eleven squamous cell carcinomas, one ameloblastoma, five secondary reconstructions, eight osteoradionecrosis, three bisphosphonate-related osteonecrosis of the jaw, and two mandibular fractures.In 23 of 32 cases, a plate thickness of 2.5mm was selected, and in nine cases a thickness of 2.0 mm was selected.Of these, 21 2.5 mm plates and nine 2.0 mm plates were implanted.Of the three centers taking part in the study, centre i planned the implantation exclusively of plates with a thickness of 2.5 mm (n = 15) and implanted fourteen of them.Centre ii planned the implantation of seven plates with a thickness of 2.5 mm, of which six were implanted.Thirty patients of the 32 patients had a planned psmp implanted.The psmp was not implanted in two patients.(male patient i/10, age (b)(6)), intraoral fistula formation and osteolysis occurred in the cortical substance of a fibula segment adjacent to a plate around 12 weeks after reconstruction with a fibula flap.After removal of a loose non-locking screw and partial removal of the reconstruction plate, the fistula and the osteolysis healed without complication.This is report 7 of 8 for (b)(4).This report is for an unknown screw/unknown quantity/unknown lot and refers to one patient where non-locking screw was removed because of loosening.

• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5701680
• MDR Text Key: 46660673
• Report Number: 2520274-2016-13022
• Device Sequence Number: 1
• Product Code: DZL
• 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: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• 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?: No
• Date Manufacturer Received: 05/16/2016
• 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
• Patient Age: 51 YR