MAUDE Adverse Event Report: SYNTHES WEST CHESTER PSI SD800.434 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.434

Device Problem Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2014

Event Type  malfunction  

Event Description

It was reported that patient specific implant (psi) bone flat placement was completed.The custom implant did not fit properly due to the soft tissue or fascia of the brain not being deep enough.The psi was cut and the lower portion of the psi was used in conjunction with 200 x 200 low profile mesh.There was no delay and procedure was completed successfully without medical intervention.This is report number 1 of 1 for (b)(4).

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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 dhr was reviewed by this investigator as part of the product development investigation ((b)(4)) and found that: "in conclusion, the patient specific implant investigated as part of this complaint passed all design and manufacturing quality checks as proscribed by the relevant work instruction for psi design and manufacture, the investigation showed that the psi implant fit the patient¿s bony defect, did not violate the inner table of the bone, met the thickness criteria at inspection and the design was approved by the operating surgeon prior to implantation; therefore there is no evidence that the design contributed to the complaint." the dhr was reviewed again and no evidence was found within the documentation to indicate that the manufacture of the implant contributed to the complaint condition.A product evaluation was performed.The investigation of the complaint articles indicates that the: review of the fcd cibfurns the report from the sc that the perimeter of the returned portion of the implant fits the patient's cranial defect.Soft tissue structures cannot be discerned from ct imaging and therefore are not part of the design.What is clears from the description and the area of the attempted modification, bony interference was not the cause of the event.The area modified was located over the open portion of the defect and soft tissue interference could be fitted to the fcd did not violate the inner table of the patient's bone.It is possible that swelling of the soft tissues of the brain may have contributed to the implant sitting high in the area where the surgeon attempted to make the implant thinner by modifying with a burr.There is no evidence that the packaging, material of construction, tolerance stack-up/mating parts/compatibility, sterilization, labeling, user technique for manufacturing specifications could have caused or contributed to the complaint description of the implant did not fit properly and was not considered further during the investigation.The dhr was reviewed and no ncr's or non-conformances were reported.Conclusion: the patient specific implant investigated as part of this complaint passed all design and manufacturing quality checks as proscribed by the relevant work instruction for psi design and manufacture; therefore, there is no evidence that the design contributed to the complaint.The investigation concluded that the reported event most likely occurred due to interference with the soft tissue at the inner surface of the implant.This is supported by evidence of the attempted surgical modification of the implant at the inner surface.The investigation will be dispositioned as confirmed because the received condition agrees with the complaint description; however, the available data gathered during the investigation did not confirm that any of the items reviewed and discussed above contributed to the reported event.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

A review of the device history records has been requested.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

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information the part was returned, an evaluation is currently in progress.

Manufacturer Narrative

Additional narrative: a product development evaluation was completed: the as received condition of the device agrees with the complaint description.The implant has been cut into two parts one was implanted and the second returned for evaluation.The returned portion of the implant was modified by the surgeon as described in the complaint.It appears that the surgeon attempted to modify the back side of the implant with a burr or other similar powered device in an attempt to make the implant thinner.The part/lot number information is not visible of the device.The apex marker is still present on the implant.Two screw holes are also visible on the implant; this is likely where the surgeon attached titanium plates to fixate the implant to the surrounding bone.This agrees with the description of the complaint and the complaint cannot be replicated with the portion of the returned device.An investigation into the device design to determine if it may have contributed or caused the event was conducted.A review of the case file for this implant showed that the implant was reviewed and approved by the product designer, an independent reviewer and the requesting surgeon according to the relevant work instructions for psi design and production.Review of the device history records also showed that the implant was inspected and passed the required checks necessary for shipment to the customer; no non-conformances were reported.A review of the 3d function check device confirms the report that the perimeter of the returned portion of the implant fits the patient¿s cranial defect.Soft tissue structures cannot be discerned from computerized topography imaging and therefore are not part of the design.It is clear that bony interference was not the cause of the event; the area modified was located over the open portion of the defect and soft tissue interference could be the only cause of the interference.The inside of the surface of the implant when fitted to the function check device did not violate the inner table of the patient¿s bone.It is possible that swelling of the soft tissues of the brain may have contributed to the implant sitting high in the area where the surgeon attempted to make the implant thinner by modifying with a burr.There is no evidence that the material of construction, packaging, sterilization, labeling, user technique or manufacturing specification could have caused or contributed to the complaint description and was not considered further during the investigation.In conclusion, the patient specific implant investigated as part of this complaint passed all design and manufacturing quality checks as proscribed by the relevant work instructions for psi design and manufacture.The investigation showed that the psi implant fit the patient¿s bony defect, did not violate the inner table of the bone, met the thickness criteria at inspection and the design was approved by the operating surgeon prior to implantation; therefore there is no evidence that the design contributed to the complaint.The investigation concluded that the reported event most likely occurred due to interference with the soft tissue at the inner surface of the implant.This is supported by evidence of the attempted surgical modification of the implant at the inner surface.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PSI SD800.434 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES WEST CHESTER; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES WEST CHESTER; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3653219
• MDR Text Key: 18866667
• Report Number: 2520274-2014-10034
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.434
• Device Lot Number: 7592090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 95