MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.429 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.429

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) (b)(4) without a valid 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.Dhr review: article & lot number do not match therefore not able to review dhr 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) reports an event in (b)(6) as follows: it was reported that a patient specific implant (psi) peek implant was approximately 2 cm too large for a patient.During the procedure, a sleeve had to be used as the psi device would no longer fit the curvature at the implant location.At this time, the patient is being monitored to see how the device looks cosmetically and to determine if the patient wants to keep ti or be revised with a new implant.No delay was noted.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.

• Brand Name: PSI SD800.429 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5034987
• MDR Text Key: 24257165
• Report Number: 2520274-2015-15528
• 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: Physician
• Type of Report: Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.429
• Device Lot Number: 01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention