MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH; SCREW, FIXATION, BONE

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Date of event: unknown.Pma / 510k: this report is for 4-6 unknown 2.0mm monocortical screws/unknown lot.Part and lot number are unknown; udi number is unknown.Implanted date: unknown.Explanted date: 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 subsequent review of the following literature article: stoor (2017) osteotomy site grafting in bilateral sagittal split surgery with bioactive glass s53p4 for skeletal stability.The journal of craniofacial surgery, volume 28, pages 1709-1716.Finland.The purpose of this prospective clinical study was to clinically and radiologically evaluate 25 patients who underwent bilateral sagittal split osteotomy (bsso) due to class ii dentoskeletal deformities.The mandibular osteotomy site defects (8¿15 mm) were augmented with bioactive glass s53p4.All the osteotomies were fixated semirigidly using 1 titanium mini plate (1.7 mm) with 6 screw holes and 4-6 monocortical (2.0mm in diameter) screws (gold, matrix orthognathic, depuy synthes, (b)(6)) on each side for both the mandible and maxilla.Of the 25 patients, 17 patients were treated with (bsso) and 8 patients were treated with bsso combined with le fort i osteotomy.In the bimaxillary patients, the maxilla was treated according to the traditional le fort i osteotomy and osteosynthesis was performed semirigidly with 4 miniplates and 4 to 6 monocortical screws/plate.There were a total of 6 male and 19 were female patients.The mean age of the patients was 33 years (range: 19¿56 years) at the time of surgery and the mean follow-up period was for 33 months (range 12¿51 months).The patients were followed up clinically 1, 2, 4, 8, and 12 weeks, 6 months, 1 year and up to 4 years postoperatively with emphasis on wound healing, stability of the osteotomy site, occlusion and the hard and soft tissue aesthetics.Radiographs taken immediately, 1 and 2 years postoperatively and a cone beam computed tomography (cbct) taken 1 year postoperatively or at follow-up evaluated stability and recontouring of the inferior mandibular border.The degree of concavity formation (height and width) was measured.The following complications were observed: patient 1 ¿ (b)(6) years old female with deep bite underwent bilateral sagittal split osteotomy (bsso).Wound dehiscence in the lower jaw was noted during first postoperative week.The osteotomy line was visible, however, with the exposed glass granules in place at the osteotomy site.The healing was uneventful without any signs of infection.Patient 2 - (b)(6) years old male with asymmetry underwent bilateral sagittal split osteotomy (bsso).Mild concavity was noted on the right inferior mandibular border.Patient 3 - (b)(6) years old female with asymmetry and open bite underwent bilateral sagittal split osteotomy (bsso).Due to the plate being exposed and loosening of a screw, osteosynthesis removed from the lower left jaw 5 months postoperatively.The healing was uneventful after the plate and screw removal.Patient 6 - (b)(6) years old female with asymmetry, deep bite and mild arthrosis on the left side underwent bilateral sagittal split osteotomy (bsso).Due to continuous pain, osteosynthesis removed from the lower jaw 5 months postoperatively.The screw in contact with the inferior alveolar nerve, was relieved from allodynia.Patient 9 - (b)(6) years old female with asymmetry, open bite and deformed condylar head on the right side underwent bimaxillary treatment (bimax).Relapse of the vertical over bite ranging from (1.5 mm) was seen 24 months postoperatively.Patient 10 ¿ (b)(6) years old male with asymmetry and deep bite underwent bilateral sagittal split osteotomy (bsso).Patient showed a smaller horizontal overjet; (1.0mm) which was due to overcorrection rather than relapse of the maxilla.Patient 13 - (b)(6) years old male with open bite and moderate arthrosis on the left side underwent bimaxillary treatment (bimax).Mild vertical relapse (0.5 mm) was noted 24 months postoperatively.Patient 15 ¿ (b)(6) years old male with asymmetry, open bite, strong resorption on left and right side underwent bilateral sagittal split osteotomy (bsso).Relapse of the vertical over bite ranging from (2.5 mm) was seen 20 months postoperatively.Patient 16 ¿ (b)(6) years old male with open bite, strong resorption on left and right side underwent bimaxillary treatment (bimax).Relapse of the vertical over bite ranging from (2 mm) was seen 24 months postoperatively.Patient also showed a smaller horizontal overjet; (1.0mm) which was due to overcorrection rather than relapse of the maxilla.Patient 18 ¿ (b)(6) years old female underwent bilateral sagittal split osteotomy (bsso).Wound dehiscence in the lower jaw on the right side was noted during first postoperative week.The osteotomy line was visible, however, with the exposed glass granules in place at the osteotomy site.24 month postoperatively relapse of open bite.During follow-up, patient presented an exposed plate without symptoms 22 months postoperatively.The plate was removed and the osteotomy site showed normal healing.Patient 20 ¿ (b)(6) years old female deep bite and moderate arthrosis on the right side underwent bilateral sagittal split osteotomy (bsso).Patient was diagnosed with loosening of the screws and plate on the right side of the mandible 2 days postoperatively.The plate and screws were removed.Reosteosynthesis was performed with 2 lag screws bicortically (2.0mm in diameter, de puy synthes, (b)(6)) followed by uneventful healing patient 21 ¿ (b)(6) years old female deep bite underwent bilateral sagittal split osteotomy (bsso).Mild concavity was noted on the left inferior mandibular border.Patient was diagnosed with chronic allodynia on the left side and needed continuous medication with 150 + 75mg pregabalin/day.Patient 22 ¿ (b)(6) years old female open bite underwent bilateral sagittal split osteotomy (bsso).Mild horizontal relapse (0.5 mm) was noted 24 months postoperatively.Patient 24 ¿ (b)(6) years old female open bite, mild resorption on left and right side underwent bimaxillary treatment (bimax).Wound dehiscence on the right lower jaw was noted during first postoperative week.The osteotomy line was visible, however, with the exposed glass granules in place at the osteotomy site.Patient was treated with immunosuppressive medication due to active rheumatic disease during the treatment and follow-up.The wound healing was delayed.Removal of all plates, both from the upper and lower jaws, was performed within 3 to 9 months postoperatively and the final healing was good.A copy of the literature article is being submitted with this medwatch.This report is for patient 3.This is report 5 of 6 for pc-(b)(4).This report is for 4-6 unknown 2.0mm monocortical screws.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7179687
• MDR Text Key: 96933072
• Report Number: 8030965-2018-50234
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR