MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION ,BONE

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

Patient Problems Unspecified Infection (1930); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown plate/screws construct/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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: suojanen, j.Et al.(2019), no differences in infections between patient-specific implants and conventional mini-plates in mandibular bilateral sagittal split osteotomy d up to 3-year follow-up, journal of cranio-maxillo-facial surgery, vol 47, pages 1181-1184 (finland).The aim of this study was to evaluate a cohort of 28 patients, treated with bilateral sagittal split osteotomy (bsso) and patient-specific implants (psis) for fixation, with regard to healing for up to 3 years.A retrospective cohort of 48 patients with conventional mini-plate repositioned mandibles was also collected for statistical analysis.The psi group had 28 patients who underwent a traditional bsso, during which drill guides were used to predrill the holes for osteosynthesis with psis, using the planmeca promodel (planmeca ltd,helsinki, finland).Three screw holes were designed on both sides for vertical osteotomy.Monocortical non-locking 6-8 mm synthes orthognathic screws (diameter1.85mm)were used for each patient.The mini-plate group had 48 patients were treated with conventional bsso, repositioned with wafers and fixated with conventional mini-plates (depuy synthes matrix orthognathic).This used 0.8- mm-thick linear or nonlinear plates with two or three screws each side, together with 1.85-mm-diameter non-locking 6-8 mm screws.The psi cohort data covered follow-up from 24 to 38 months (average 30 months) and the mini-plate cohort from 12 to 63 months (average 50 months).The following complications were reported as follows: table 1 (psi).A (b)(6) year old female patient had a wound infection on the left side 1 week postop.Psi was removed at 4 months.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old male patient had a wound infection on the left side 3 weeks postop.Psi was removed at 6 months.He was with a deep bite and retrognathia mandible.A (b)(6) year old male patient had artrite activation at 12 months, had a relapse.He was diagnosed with apertognathia and retrognathia mandible.A (b)(6) year old male patient had a late psi infection on the right at 19 mo.Psi was removed.He was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old male patient had a late psi infection on the right at 7 mo.Psi was removed.He was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had a reoperation 2 days due to open bite, was tmj disc replacement.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had an open bite due to condyle resorption 21 months postop.She was diagnosed with an anterior open bite and retrognathia mandible.A (b)(6) year old female patient had a wound dehiscence at 10 days which resolved spontaneously.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had a wound infection on the right side 3 weeks postop.Psi was removed at 6 months.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had a wound infection on the left side 1 week postop.Psi was removed at 3 months.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old male patient had a wound infection on the right side 4 weeks postop.Psi was removed at 3 months.He was diagnosed with a deep bite and a large over jet.A (b)(6) year old female patient had a complication due to subjective symptoms.Psi was removed at 16 months.She was diagnosed with a deep bite and retrognathia mandible.Table 2 (mini plates).A (b)(6) year old female patient had swelling on the left side at 8 months, no clear infection and it resolved spontaneously.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old male patient had a plate infection on the left side at 2 months.Plate was removed at 4 months.He was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had a relapse.She had a le fort i osteotomy 36 months.She was diagnosed with a retrognathia mandible and a juvenile oligoarthritis.A (b)(6) year old female patient had a wound infection on the right side after 1 week.It was resolved with amoxicillin.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had a wound dehiscence on the left side at 1 week.She had soft tissue revision at 3 months.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had a had a plate infection on the right side at 1 month.Plate was removed at 3 months.She was diagnosed with a distal bite and retrognathia mandible.A (b)(6) year old male patient had a wound infection on the left side after 2 weeks.Plate was removed at 5 months.He was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old male patient had a relapse and an anterior open bite of 0.5mm.He was diagnosed with an anterior open bite and retrognathia mandible.A (b)(6) year old female patient had a reoperation at 2 days due to open bite, wound opening on both sides at 10 days.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had a wound infection on the left side after 2 weeks.She took several antibiotics and had a revision at 2 months.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old male patient had a plate infection on the left side at 2 months.Plate was removed at 4 months.He was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old male patient had a wound dehiscence on the right side at 1 week.Plate was removed at 3.5 months.He was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old male patient had a plate removal at 12 months as per his request.He was diagnosed with a scissor bite.A (b)(6) year-old female patient had a wound infection at 1 week and was resolved with clindamycin and metronidazole.She was diagnosed with a retrognathia mandible.A (b)(6) year old female patient had a plate infection at 3 weeks.Plate was removed at 5 months.She was diagnosed with a distal bite and distal bite.A (b)(6) year old female patient had a wound infection at 1 week which was resolved with amoxicillin.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old male patient had a wound dehiscence on the left side at 1 week which was resolved with chlorhexidine mouth rinse.He was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had swelling on the left side at 2 months which resolved spontaneously.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had an infection at 10 days.She had a revision at 2 weeks.She had late plate infection at 23 months.The plate was removed.She was diagnosed with an anterior open bite and retrognathia mandible.A (b)(6) year old female patient had a wound infection at 10 days which resolved with kefalexin.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had an osteosynthesis failure 4 days which was reoperated.She was diagnosed with an anterior open bite and retrognathia mandible.A (b)(6) year old female patient had a wound infection on both sides.Plate was removed at 5 months.She was diagnosed with a deep bite and retrognathia mandible.A (b)(6) year old female patient had a relapse at 18 months.Plate was removed at 5 months.She was diagnosed with an anterior open bite and retrognathia mandible.A (b)(6) year old female patient had a late plate infection.Plate was removed.She was diagnosed with a deep bite and retrognathia mandible.This report is for an unknown synthes matrix orthognathic system (depuy synthes) and monocortical non-locking 6-8 mm synthes orthognathic screws.This report is for one (1) unknown plate/screws construct.This is report 6 of 10 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10409820
• MDR Text Key: 209841655
• Report Number: 8030965-2020-06026
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/14/2020
• 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
• Patient Age: 25 YR