MAUDE Adverse Event Report: SYNTHES USA; IMPLANT FIXATION DEVICE

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following journal article, reconstruction of alveolar defects using titanium-reinforced porous polyethylene as a containment device for recombinant human bone morphogenetic protein 2 hart.K, bowles.D, american association of oral and maxillofacial surgeons.J oral maxillofac surg 70:811-820, 2012.A case review was performed of 8 patients who had undergone rhbmp-2 bone grafting using porous polyethylene as the containment device.Eight maxillary and two mandibular alveolar defects were grafted using rhbmp-2 and titanium-reinforced porous polyethylene as a soft tissue barrier.One patient received autologous ramus bone in addition to the rhbmp-2.All patients were followed up by clinical examination and periodic radiographic studies for 6 months to 2 years.Implant-borne prostheses were fabricated on all successful grafts.A (b)(6) man.At postoperative day 7, the synpore barrier was exposed and mobile.The palatal positional screw was loose and no longer securing the barrier on the palatal surface.Because of the instability, the barrier and graft were removed.The area was subsequently regrafted with autologous and allogeneic bone and an implant later placed.Of the 10 grafted alveolar defects, 2 (20 percent) resulted in early exposure of the containment devices, were removed, and resulted in no bone formation.One of the 10 defects (10 percent ) became exposed 3 months postoperatively and resulted in only moderate bone formation.In the 7 nonexposed cases ((70 percent), bone formation was excellent, and implants were successfully placed.This is report 1 of 4 for (b)(4).This report is for a unknown synpor.

Manufacturer Narrative

This device is used for treatment, not diagnosis.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.

• Type of Device: IMPLANT FIXATION DEVICE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4476358
• MDR Text Key: 5326819
• Report Number: 2520274-2015-10571
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• 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: 01/22/2015
• 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: 50 YR