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

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following journal article, "long-term functional outcome of mandibular reconstruction with stainless steel ao reconstruction plates" minnen, b.V., nauta, j.M., verney, a., bos, r.R.M., roodenburg, j.L.N.(2002).(b)(4) journal of oral and maxillofacial surgeons 40:144-148.Study conducted in (b)(4).The study retrospectively reviewed the records of 36 patients (18 men and 18 women), aged between 20 and 79 whose mandibular defects had been reconstructed with stainless steel arbeitsgemeinschaft für osteosynthesefragen (ao) reconstruction plates from the first plate in (b)(6) 1988 until (b)(6) 1997.Patients with an ao plate in situ after the operation were included.Patients with failed reconstructions were compared with those in whom the procedure had been successful.The reconstruction was considered a failure if the plate had to be removed for complications or if the patient still had the plate in situ, but with unresolved complications.In 35 patients a tumor was the reason for mandibular resection and one patient had chronic osteomyelitis.The mean follow-up was 39 months.4 patients were withdrawn because they developed early recurrent disease.Fifteen had successful reconstruction.In 17 patients the reconstruction failed, in 13 of whom the plates were removed for complications after 1-24 months.Four other patients still had their plates, but had unresolved plate-related complications.Twenty-six patients were alive at the date of evaluation.A total of 246 unknown screws were used, 21(9%) of which became loose.The loosening of an unknown quantity of unknown screws.This report is 2 of 6 for (b)(4).This report is for an unknown quantity of screws.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(4).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: 4717906
• MDR Text Key: 5736166
• Report Number: 2520274-2015-12919
• 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: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• 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
• Date Manufacturer Received: 04/10/2015
• 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