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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Literature article received: this report is being filed after the subsequent review of the following literature article."single, non-compression superior-lateral border plate in the treatment of mandibular angle fractures; a retrospective study." yip, e.K., yamashita, d.D.R.(2014).Aaoms.A retrospective chart review of patients was conducted with isolated, bilateral, or combination mandibular angle fractures at the lac+usc medical center over the course of one year 2010-2011 with irb approval.The sample was composed of patients with at least one angle fracture, with or without other mandible fractures.Treatment consisted 2.3 (stryker) or 2.4 (synthes) 4- or 5-hole, superior lateral border plate orif.Treatment included an intra-oral approach to expose and reduce the fracture, with plate fixation established trans-facially with trochar which allowed the use of bicortical screws at the proximal segment, and either bicortical or monocortical screws at the distal segment depending on presence of dentition.The sample composed of 42 patients; 40 men and 2 women, and 45 total angle fractures.Common complications was malocclusion, occurring in 4/45 (8.9%) of patients immediately postoperatively.Infection occurred in 3/45 (6.7%) patients and 1 instance (1/45, 2.2%) of hardware failure with loose proximal screws requiring removal and closed reduction treatment.Unknown screws and refers to the loosening of unknown screws requiring removal and closed reduction treatment.This report is 1 of 2 for (b)(4).This report is for an unknown quantity of screws.The origin of this abstract is unknown.

Manufacturer Narrative

Device used for treatment, not diagnosis.Literature article received: this report is being filed after the subsequent review of the following literature article."single, non-compression superior-lateral border plate in the treatment of mandibular angle fractures; a retrospective study." yip, e.K., yamashita, d.D.R.(2014).Aaoms.This report is for unknown screws/unknown quantity/unknown lots.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.

• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• 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: 4729785
• MDR Text Key: 5585969
• Report Number: 2520274-2015-13296
• 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
• Report Date: 04/10/2015

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2015
• Initial Date FDA Received: 04/27/2015
• 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