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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI PSPC MATRIXMANDIBLE 7X23 H ANGLE RECON PL/LEFT/2.0MM THK; BONE PLATE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI PSPC MATRIXMANDIBLE 7X23 H ANGLE RECON PL/LEFT/2.0MM THK; BONE PLATE Back to Search Results
Model Number SD449.503B
Device Problem Defective Device (2588)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 10/30/2019
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that on (b)(6) 2019, the surgeon was not happy with the fit of the matrix mandible plate.The surgeon contoured the bone graft (fibula) to a preformed plate to fit the mandible.There was a sixty (60) minute surgical delay.The procedure was successfully completed.Patient status is unknown.Concomitant device reported: unknown matrixmandible screws (part # unknown, lot # unknown, quantity # unknown).This complaint involves one (1) device.This report is for one (1) ti pspc matrixmandible 7x23 h angle recon pl/left/2.0 mm thk.This is report 1 of 1 for (b)(4).
 
Event Description
Concomitant device reported: patient specific instrument/implant kit (part # sd.900.001 , lot # unknown, quantity # 1), titanium (ti) matrixmandible screw self-tapping 6mm (part # 04.503.406.01, lot # unknown, quantity # 2), ti matrixmandible screw self-tapping 8mm (part # 04.503.408.01, lot # unknown, quantity # 2), ti matrixmandible screw self-tapping 12mm (part # 04.503.408.01, lot # unknown, quantity # 9), ti matrixmandible screw self-tapping 14mm (part # 04.503.414.01, lot # unknown, quantity # 1), ti matrixmandible locking screw self-tapping 8mm (part # 04.503.608.01, lot # unknown, quantity # 5), unknown screws (part # 04.503.601.01,, lot # unknown, quantity # 5), ti matrixmandible locking screw self-tapping 12mm (part # 04.503.612.01, lot # unknown, quantity # 2).
 
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.Updated concomitant devices therapy date: (b)(6) 2019.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.
 
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.H3, h6: investigation summary: the device was not returned.The investigation was performed by product development (pd).Design review: an investigation into the device design to determine if it may have contributed or caused the event was conducted.Pspc plates (patient specific plate contouring) are customized devices intended to repair/reconstruct mandible defects.Each pspc is custom contoured for an individual patient.The plate is contoured using standard surgical tools to conform to a 3d printed model which matches the specific defect/reconstruction, patient anatomy and surgical request.Patient ct image files are provide to depuy synthes¿ planning partner (materialise) by the requesting surgeon and imported into a segmentation system to distinguish the bony elements of the mandible from soft tissue.Materialise, in consultation with the patient¿s surgeon, simulates reconstruction of the patient¿s mandible.The output of the surgical planning session is a digital file of the planned reconstruction suitable for 3d printing.Prior to shipment, the fit and symmetry of the contoured plate is checked against the 3d printed model by an independent reviewer.Once the contouring has been reviewed, the plate is dimensionally and functionally inspected by quality inspectors to verify the contouring and finishing process did not affect the dimensions or function of the plate.Review of the case file for this implant showed that the implant was reviewed and approved by an independent reviewer according to the relevant work instructions for pspc design and production.Review of the device dhr also showed that the implant was inspected and passed the required checks necessary for shipment to the customer.On october 30, 2019 the depuy synthes chu was notified that the requesting surgeon was disappointed that the implant contoured for his patient did fit as expected.The complaint description indicated that surgeon refashioned the fibula grafts to fit the plate in the or which extended the surgery by approximately 60 minutes.The description did not report any complications or intent to reoperate.Upon being notified of complaint the psi group reviewed the case file for this request.Review of the case file showed that prior to contouring this implant the materialise team simulated the resection of a large defect on the anterior mandible and replaced the resected portion with 3 segments of the patient¿s fibula as graft.This reconstructed model was 3d printed by depuy synthes and a plate was contoured to match the planned reconstruction.Additionally, review of the images of the completed plate prior to shipment showed that the contoured plate matched the reconstructed 3d model.The pspc implant investigated as part of this complaint passed all design and manufacturing quality checks as proscribed by the relevant work instructions for pspc contouring.The investigation revealed that the pspc was contoured according to the resection boundaries specified by the requestors and the plate matched the contour of the 3d printed model.Additional follow-up with materialise should be conducted to determine if the resection guides contributed to the event.The investigation for the pspc plate will be dispositioned as unconfirmed.Conclusion: the complaint was not confirmed during investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: the dhr was reviewed as part of the product development investigation.No ncr¿s or non-conformances were reported.Device history review: no non-conformances were revealed during dhr review.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.
 
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Brand Name
TI PSPC MATRIXMANDIBLE 7X23 H ANGLE RECON PL/LEFT/2.0MM THK
Type of Device
BONE PLATE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key9330269
MDR Text Key170276812
Report Number2939274-2019-62244
Device Sequence Number1
Product Code JEY
UDI-Device Identifier10887587004556
UDI-Public(01)10887587004556
Combination Product (y/n)N
PMA/PMN Number
K063790
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 12/04/2019
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 Model NumberSD449.503B
Device Catalogue NumberSD449.503B
Device Lot Number24P1710
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/30/2019
Initial Date FDA Received11/15/2019
Supplement Dates Manufacturer Received12/04/2019
06/30/2020
Supplement Dates FDA Received12/18/2019
06/30/2020
Patient Sequence Number1
Treatment
UNK - SCREWS: MATRIXMANDIBLE
Patient Outcome(s) Required Intervention;
Patient Age76 YR
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