MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: CMF; SCREW, FIXATION, INTRAOSSEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Decreased Sensitivity (2683); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

A total of 18 patients (12 male and 6 female) were included in the study.9 patients were randomized to the mdo group and to the ssro group.The mean ages of the mdo group and ssro group were 40.7 years (s.D.14.3 years) and 44.7 years (s.D.7.1 years), respectively.This report is for an unknown synthes screws/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: tsui, w.K., yang, y., mcgrath, c., and leung, y.Y.(2019), mandibular distraction osteogenesis versus sagittal split ramus osteotomy in managing obstructive sleep apnea: a randomized clinical trial, journal of cranio-maxillo-facial surgery, vol.47 (5), pages 750¿757 (hong kong).The aim of this randomized clinical trial is to compare the effectiveness of mdo and ssro in the treatment of moderate-to-severe osa.The specific aims of the study were to compare the osa cure rate (ahi < 5/hour) and treatment success rate (50% reduction of ahi and ahi< 20/hour) of patients who received mdo or ssro at 12 months after treatment, and to compare the longitudinal ahi changes and surgical morbidities of patients who received mdo or ssro.A total of 18 patients (12 male and 6 female) were included in the study.9 patients were randomized to the mdo group and to the ssro group.The mean ages of the mdo group and ssro group were 40.7 years (s.D.14.3 years) and 44.7 years (s.D.7.1 years), respectively.Surgery was performed using a piezoelectric saw (synthes, monument, usa) and an intra-oral bone-borne single-vector mandibular distractor (cmf distractor, synthes, monument, usa) in the mdo group.The mean follow-up period was unknown.The following complications were reported as follows: mdo group: it was also noted that the patients in the mdo group required a prolonged stay in the intensive care unit at the immediate post-operative period due to the swollen airway.1 patient had ahi of 23.5/hour at t4 and the treatment was considered unsuccessful.There were 4 cases (44.4%) of major complications.1 patient developed hospital-acquired pneumonia on the second postoperative day in the icu.Extubation was delayed to the postoperative 5th day until the pneumonia was controlled with a vigorous antibiotics regime and chest physiotherapy.The patient recovered subsequently.2 patients presented with nonunion of mandible and 1 case of non-union of maxilla.All 3 cases required re-operation for re-fixation and additional curettage/bone grafting.All three cases healed uneventfully after the reoperation.6 patients had post-operative infections in the mdo group around the distractors.1 patient had occlusion discrepancy (anterior open bite).3 patients had occlusion discrepancy (posterior open bite).1 patient had mild subjective neurosensory deficit.3 patients had moderate subjective neurosensory deficit.4 patients had severe subjective neurosensory deficit.1 patient had facial asymmetry.Skeletal relapse (i.E.Posterior movement) was noted at post-operative 3 months (t2) onwards to 2 years (t5), with a mean total relapse of 0.32mm (s.D.0.20 mm) in 2 years.This report is for unknown synthes screws.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - SCREWS: CMF
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11066475
• MDR Text Key: 225742668
• Report Number: 8030965-2020-09941
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention