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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Literature article received: this report is being filed after the subsequent review of the following literature article."the free vascularized flap and the flap plate options: comparative results of reconstruction of lateral mandibular defects" shpitzer, t., et al.(2000).The laryngoscope, 110:2056-2060.Study conducted in (b)(4).A retrospective comparative study of short-and longterm outcome of three different reconstruction techniques for lateral defects was performed.A total of 57 patients were included, of 27 had a plate and pedicled pectoralis major myocutaneous flap (pmmf group), 16 had a plate and free radical forearm flap (frff group), and 14 had an osteocutaneous free flap.Plates had to be removed in 7 of the 27 patients in the pmmf group and 2 of the 16 in the frff groups; none of the 14 osteocutaneous free flaps failed.There were no perioperative deaths in the pmmf group 11% (3 of 27) general complications rate consisted of pneumonia (2) and delirium tremens (1).Failure at recipient site occurred in 7 (26%) cases.Failure consisted of extraoral exposure of the plate (1), plate fracture (3), loosening of screws (2), and pmmf failure (1).Two patients required removal of the plate and subsequently received a vascularized fibula flap, two patients had repeat plate contouring, two patients had plate removal only, and one patient had a fasciocutaneous free flap.In the frff group, there were no perioperative deaths, general complications occurred in 12% of cases (2 of 16 patients) and consisted of pneumonia (1) and congestive heart failure (1).In 2 of 16 cases (12%) reconstruction failed.Failure consisted of intraoral plate exposure (1) and plate fracture (1).Both patients had repeat plate contouring.Unknown screws and refers to the loosening of unknown screws.This is report 2 of 4 for (b)(4).This report is for unknown ao plates.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).This report is for unknown screws/unknown quantity/unknown lot.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: 4730106
• MDR Text Key: 5748769
• Report Number: 2520274-2015-13422
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/08/2015
• 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