MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.512 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.512

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Sedation (2368)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device has not been reported as explanted.Device history record review: documentation shows this device was manufactured, etched, inspected, cleaned and forward for plasma treatment as per model specifications.No inconsistencies were found during these processes.There were no non-conformance reports issued against this work order.Date of release to warehouse was 29 december 2014.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

It was reported that there was an issue with two patient specific implant (psi) case.The implant required about two hours of burring to make it fit properly.The verification models received had fit fine, but the actual implants seemed larger.This occurred during the initial surgery and psi was used to cover a defect in the frontal bone.An additional mesh was used to make sure the transition from implant to bony surface was smooth.Surgery was completed successfully without further medical intervention required.The product is implanted in the patient and will not be returned.No additional information is available.This is report 1 of 1 for (b)(4).

• Brand Name: PSI SD800.512 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: 5250593
• MDR Text Key: 32142471
• Report Number: 2530088-2015-10709
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2015

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 Catalogue Number: SD800.512
• Device Lot Number: 7887253
• Other Device ID Number: (01)10887587065724(10)7887253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention