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

Catalog Number SD900.106

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Sedation (2368)

Event Date 07/30/2015

Event Type  Injury  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing site: (b)(4)- manufacturing date: july 10, 2015.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 the product that would contribute to this complaint condition.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that both the intermediate and final splints did not fit in the patient during an orthognathic bimaxillary surgery conducted on (b)(6) 2015.On the left side of both splints, the maxilla impressions were out 4-5 mm buccal to the molar cusps.This meant that free-hand adjustments to the osteotomies were needed to achieve the desired correction.These adjustments added to the overall surgical time and compromised the accuracy of the final position.However, the surgeon was confident that the correct outcome was achieved.A sixty (60) minute delay was noted.No further information is available.(b)(4).

Manufacturer Narrative

Manufacturing investigation evaluation: while reviewing the segmentation and the segmentation quality check performed on the mandible and maxilla for this case, no inaccuracies were found in the process step as it was performed correctly and according to the work instructions.Moreover, the cast registration was performed correctly.The patient has brackets on the molars, which were included correctly on the segmentation.Moreover, if any orthodontic work on the patient occurred between the time the images were provided and the surgery date, it would not have had an impact as the age of the images is less than 1 month (which is in accordance with the specifications of the product).Moreover, it can be seen that no induced cant was present, as mandible and maxilla aligned correctly.This check was performed on the slices 80-125 coronal view, which shows that the cast aligns with the dental information on the ct images.It was noticed that there is a cant on the left of the mandible side with respect to the right side (lower on left side compared to right side by ~ 2mm).It appears that this cant was not noted during the approval of the surgical plan done by the surgeon, and therefore, if during surgery the surgeon was not expecting a cant, his desired position intra-operatively would have been different.This however, could not have caused the splints to not fit during surgery, but only explains 2mm of the 4-5mm offset reported by the complainant.The 2mm cant present on the left of the mandible side was indicated in the case report provided to the surgeon for approval where no indication of any planned movement by the surgeon was indicated in the coronal plane (no cant correction).The surgeon, therefore, was made aware of this cant, but he did not indicate during the planning session or the approval of the surgical plan that a correction will take place.The guide design of the intermediate and final splints was performed correctly and according to the work instructions and approved preferences of the surgeon.Both intermediate and final splints accounted for space for the brackets in the molars of the patient and therefore could not have caused any interference or issues with the fitting on the patient¿s teeth.The release for distribution form was investigated, as well as the case report from production.Both final and intermediate splints were manufactured correctly and within the manufacturing specifications.A fit test was performed with the printed segmented 3d model of the teeth as dental casts are not provided to materialise for australian cases.The fit test was successful for both splints.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.

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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: 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5004647
• MDR Text Key: 23059757
• Report Number: 3000270450-2015-10157
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• 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: ME15-UTI-LIS-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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