MAUDE Adverse Event Report: SYNTHES SELZACH PATIENT SPECIFIC SPLINT ORTHOGNATHIC, FINAL; TEMPLATE

Catalog Number SD900.106

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Sedation (2368)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

Due to intra-operative issues the device was not implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Part number: (b)(4), synthes lot number: me16-rax-fij-02: release to warehouse date: june 30, 2016.Mfg site: (b)(4).The article (b)(4) with the lot number me16-rax-fij-02 is a part of a kit with the number (b)(4) and the lot number me16-rax-fij.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in the (b)(6) is as follows; it was reported that during a bilateral sagittal split osteotomy (bsso), the final splint was accurate in terms of fitting into the max and man occlusion, however it was way too thick posteriorly resulting in huge posterior open bites bilaterally.This was not reflected in the surgical plan.The final splint had a posterior open bite of approximately 5mm on both the left and right sides.Splint was seated correctly as far as occlusion was concerned.Although a posterior open bite is visible in the proplan plan, surgeon stated the posterior open bite on the patient was much larger than on the report.This posterior open bite resulted in the surgeon removing the bicortical positioning screws in the mandible, altering the bsso cut, and repositioning the mandible in final position without the use of a final splint.This resulted in approximately 90 minutes of delay to the surgery.There was no report of additional injury to the patient.The surgeon was satisfied with the outcome of the procedure.This is report number 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation was completed for part # sd900.106, lot # me16-rax-fij-02.The device history record was investigated for the final splint.No inaccuracies were found on the image quality, segmentation, planning, guide design and implant design steps.The provided occlusion scan of the patient shows a posterior open bite of approximately 5mm on the right side and 3mm on the left side of the patient¿s teeth.The patient occlusion was discussed during the planning session and approved by the surgeon in the provided case report.Moreover, the designed and manufactured final splint properly translated the surgical planning, accounting the approved posterior open bite.Therefore, it can be concluded that the manufactured devices met specifications and the approved preferences of the surgeon.Corrected data: (b)(4).Device 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: PATIENT SPECIFIC SPLINT ORTHOGNATHIC, FINAL
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5924378
• MDR Text Key: 53799622
• Report Number: 3000270450-2016-10216
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD900.106
• Device Lot Number: ME16-RAX-FIJ-02
• Other Device ID Number: (01)07611819490635(10)ME16-RAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention