MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.526 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.526

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 02/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device not reportedly explanted.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review - manufacturing date: 02/25/2016.No ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition 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 while implanting a patient specific implant (psi) on (b)(6) 2016.The implant reportedly did not seat properly in the defect initially and required a significant amount of burring along the anterior and posterior edges of the implant.Once the psi was able to lay in the defect, there was a slight amount of rocking that required an additional two (2) plates and there was an 8mm gap along the posterior edge of the implant.Roughly 10-12 minutes were added to the surgery.The two (2) plates used had no issues, only the psi was not fitting properly, patient is reportedly doing fine.This is report 1 of 1 for (b)(4).

• Brand Name: PSI SD800.526 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: 5495098
• MDR Text Key: 40157630
• Report Number: 2530088-2016-10077
• 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: Other
• Type of Report: Initial
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.526
• Device Lot Number: H048222
• Other Device ID Number: (01)10887587065854(10)H048222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention