MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: PLATE/SCREWS-CRANIOFACIAL; PLATE, FIXATION, BONE

Catalog Number UNK - CONSTRUCTS: PLATE/SCREWS

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

Patient Problems Eye Injury (1845); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Pma/510k: this report is for an craniofacial plate/screws construct and patient specific implants lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: 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.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

This report is being filed after the review of the following journal article: hajibandeh j., be a., and lee c.(2021), custom interlocking implants for primary and secondary reconstruction of large orbital floor defects: case series and description of workflow, journal of oral and maxillofacial surgery, vol.79 (xx), pages 2539.E1-2539.E10 (usa).The aim of this case series is to present a novel solution combining virtual surgical planning and the use of a 2-piece, interlocking patient specific implant to address the problem of limited surgical access.A total of 2 patients (case 1: 62-year-old male; case 2: 52-year-old male) were presented.Both patients were implanted with 2-piece patient specific titanium implant, using virtual surgical planning software (materialise, belgium) and the assistance of a clinical engineer (depuy synthes, ma) the bony architecture of the intact side of the orbit was mirrored onto the other side, for primary and secondary procedures, respectively.No complications for case 1.Reported complications were as follows: a 52-year-old male patient (case 2) underwent orif of his facial fractures through a bicoronal, transfacial (via the wound), and intraoral approaches on hospital day 5.The left orbital floor was accessed through the open wound and fixated using a preformed anatomic titanium plate (depuy synthes, raynham, ma).Ct scan on postoperative day 1 showed over-projection of the left zygomaticomaxillary complex (zmc) fracture.Decision was made to return to the operating room on hospital day 7 for revision of the left zmc and orbital floor fractures.The hardware from both fractures were removed and re-reduction of bony segments performed.The left orbital floor was again plated with a preformed anatomic titanium plate (depuy synthes, raynham, ma).After completion of fixation an intraoperative ct scan demonstrated satisfactory projection of the malar process and improved reduction of the orbital floor and zmc.The patient was evaluated in the outpatient setting 3 weeks postoperatively.He complained of ongoing primary gaze diplopia and on exam had enophthalmos and dystopia.Given his symptoms and lack of improvement we elected to perform a secondary orbital floor reconstruction.Preoperative ct scan was notable for a previously repaired left orbital floor defect measuring 3.0 x 3.7 cm.Volumetric measurements revealed a left orbital volume of 30.0 cm3 compared to 27 cm3 of the normal side.There was again concern regarding repair of such a large defect using a single plate, this time in the setting of scarring secondary to the initial trauma and prior operations.Using virtual surgical planning software (materialise, belgium) and the assistance of a clinical engineer (depuy synthes, ma) the intact right orbit was mirrored onto the left.A custom drill guide and 2 piece, interlocking patient specific titanium implant was fabricated to replicate the patient¿s anatomy (materialise, belgium) (fig 6).The patient was seen for outpatient follow-up until 2 months postoperatively.With the left orbital volume reconstituted, his enophthalmos and diplopia resolved and he clinically demonstrated appropriate globe projection and pupillary position.However, he briefly suffered from hsv keratitis of the left globe which was successfully treated with a course of antiviral therapy.This report is for an unknown synthes craniofacial plate/screws construct and patient specific implants.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.Complaint interpretation: one patient suffered from hsv keratitis.Although distributed by depuy synthes syn, the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the depuy synthes customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.A manufacturing investigation was performed by supplier.Reference pi attachment ¿c-med-22-6651_encrypted_¿ for completed investigation, which is summarized below.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Given that there is no indication of any issue with the device, a brief investigation into a potential root cause will be done in the other section.During the investigation it was reviewed if there could be a potential link between the hsv keratitis and the orbital implants.Given the characteristics of the herpes virus, it could be excluded that the orbital implants were in any way related to the hsv keratitis.No additional information was received from the surgeon/author of the article.The overall complaint was not confirmed for the unk - constructs: plate/screws-craniofacial.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required.D4: the catalog has been updated to reflect the correct information.

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS-CRANIOFACIAL
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14919110
• MDR Text Key: 295313656
• Report Number: 2939274-2022-02471
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Device Catalogue Number: UNK - CONSTRUCTS: PLATE/SCREWS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male