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 No Code Available (3191)

Event Date 04/29/2017

Event Type  Injury  

Manufacturer Narrative

Patient age/date of birth and weight are unknown.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).(b)(4).Part sd980.001, lot me16tuhqul: manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: april 19, 2017.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.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the patient had a bilateral posterior open bite two to three (2-3) millimeters.This occurred when doing the mandible movement component of the surgery; it was after plating the mandible using the final splint, as positioning guide, and using the mandible patient specific plates.The surgeon attempted to correct this via several steps.He moved the mandible plates and re-plated; the patient still had a bilateral posterior open-bite.He took the splint out and re-plated; the patient still had a bilateral posterior open-bite.He took the splint out and removed cut the bottom bar off double bars on patient specific mandible plates; this is the step that stopped the posterior open bite.There was a surgical delay to procedure of ninety (90) minutes.There was no adverse event to patient reported.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Complainant part is no longer expected to be returned for manufacturer review/investigation.A product investigation was completed: complained issue could not be replicated and/or confirmed based on the available information.No pictures and/or x-rays were provided and no material was returned for investigation.Device history record (dhr) reviews were performed for the affected lots, no abnormalities or deviations were detected, which could lead to the complaint failure.No non-conformance reports were marked in the dhr during production.Planning, guide design and production steps that could explain a posterior open bite.Therefore, it is determined that the materialise devices performed as intended.In the planning report sent to the surgeon, an overlap of 0.8 mm was indicated in the posterior maxillary region.Such measurements in the planning report indicate approximate overlaps and potential bony reductions needed in the posterior maxilla that are not guided with the titanium 3d printed guide for midface.As these bony reductions are done free hand by the surgeon, it is possible that the surgeon removed too much bone of the maxilla in this region.This could potentially have led to a slight discrepancy in final position of the maxilla compared to the surgical plan.A shallow final splint was designed for this case as per the surgeon¿s request.Potentially, the surgeon did not fully lock the teeth of the mandible in the teeth impressions of the shallow splint posteriorly.Combined with the potential discrepancy in maxillary position, this could have led to a posterior open bite as indicated by the complainant.This however, cannot be confirmed based on the available information.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6593612
• MDR Text Key: 76033482
• Report Number: 3000270450-2017-10181
• 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: 04/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• 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-TUH-QUL_02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention