MAUDE Adverse Event Report: SYNTHES USA; SCREW

Device Problem Positioning Problem (3009)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article, "the use of biodegradeable plates and screws to stabilize facial fractures" r.Bryan bell, dds, md and craig s.Kindsfater, dds.(2006).American association of oral and maxillofacial surgeons j oral maxillofac surg 64:31-39.A study was conducted to review the demographics and outcome of patients with a variety of facial fractures that were stabilized with poly(l-lactide) pl bone plates and screws.The study recorded 295 consecutive patients with facial fractures treated by open reduction and internal fixation (orif), performed by the author from 2001 through 2004.The patients were selected to receive biodegradable fixation on the basis of mechanism of injury, the degree of bony displacement demonstrated on clinical and radiographic examination, patient age, and fracture pattern or location; 281 patients met the criteria for inclusion in the study with follow-up of 3 weeks to 3 yers.59 (21%) patients were identified as having biodegradable plates and screws.Complications occurred in 16 patients overall (6%) and included infection (n=8), malunion (n=4), nonunion (n=2), enopthalmos (n=1), ectropion (n=1), and entropion (n=1).Of these 2 patients were treated with resorbable plates and screws; 1 patient with zygomatico-maxillary complex (zmc) fracture developed a sterile abscess that presented 1 year postoperatively and responded to local measures.Another patient with a le forte i fracture developed an anterior open bite necessitating le forte i osteotomy for correction.A third patient, a (b)(6) with a bilateral mandible fracture stabilized with 2.0-mm biodegradable plates and screws, developed a local inflammatory reaction approximately 1 year after surgery that required no treatment and resolved spontaneously.All patients eventually went to satisfactory healing with favorable restoration of form and function.This report is for serious injury described as anterior open abcess.This is report 4 of 6 for (b)(4).This report is for unknown pl bone plates and unknown screws.A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The use of biodegradable plates and screws to stablize facial fractures, r.Bryan bell, dds, md and craig s.Kindsfater, dds.(2006).American association of oral and maxillofacial surgeons j oral maxillofac surg 64:31-39.Additional narrative: this report is for unknown screw resorbtion, device and lot number.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.(b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: SCREW
• 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: 4597293
• MDR Text Key: 16863135
• Report Number: 2520274-2015-11748
• 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: Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• 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?: Yes
• Date Manufacturer Received: 05/14/2015
• 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