MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.436 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.436

Device Problem Fitting Problem (2183)

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

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient initials: (b)(4).Patient age, gender and weight are unknown.(b)(4).Device has not been reported as explanted.(b)(6).Without a lot number the device history records review could not be completed.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 (b)(4) reported that a patient specific implant (psi) peek implant was not fitting properly.It was reported that during surgery, there was a discrepancy of approximately four (4) millimeters on one side and two (2) millimeters on another between the patient's defect and the borders of the implant.No additional medical intervention was required.There was no time delay and the procedure was completed without further complications.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device.The subject device was not returned to the manufacturer for investigation therefore, no determination could be made regarding the condition of the patient specific implant.The device design (including patient ct image files), materials of construction, packaging, sterilization, labeling, user technique and manufacturing specifications were considered during the investigation to determine if any of these factors may have contributed or caused the complained event.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 fcd device was reproduced and reevaluated as part of the investigation.The fcd evaluation showed that the implant fit the defect as intended and did not show any signs of gapping as described in the complaint.The investigation did reveal that implantation of the device occurred approximately 5.5 months after ct scan acquisition date, changes to the patient anatomy between the date of scan and device implantation may have contributed to the complaint event.The investigation was dispositioned as unconfirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The original date of awareness was reported as january 5, 2016 on the initial medwatch in error.The correct date of awareness for the issue was january 4, 2016.The date has been updated in the appropriate b4 field.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

Additional narrative: review of the device history record showed that the implant was manufactured, inspected, and passed the required checks with no non-conformances identified.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.

• Brand Name: PSI SD800.436 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5379420
• MDR Text Key: 36647243
• Report Number: 2520274-2016-10348
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK053199
• 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: Initial,Followup,Followup,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.436
• Device Lot Number: 9947456
• Other Device ID Number: (01)10887587065083(10)9947456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1