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

Catalog Number SD800.434

Device Problem Fitting Problem (2183)

Patient Problem Sedation (2368)

Event Date 04/16/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) follows: the patient specific implant (psi) did not have the perfect fit.The surgeon had to cut the upper left side of the implant to make it fit the skull defect.The other three sides of the implant did had a perfect fit.The surgery was reportedly prolonged about 30 minutes.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.Device not reportedly explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review ¿ no ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product development evaluation was completed: the part was not received for evaluation.The reconstruction was designed according to the visual defect represented in the patient¿s ct dataset.The 3d model, created according the received ct dataset has been analyzed, no association to the manufacturing processes were found.However, the tissue expander may have had an influence on the threshholding as the expanded tissue resulted in a variation in image density around or near the defect.The psi was designed to feather/blend the edge where the increased density of soft tissue was present.The threshholding could be adjusted to compensate for this while boney margins remained.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 SD800.434 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4836072
• MDR Text Key: 5907878
• Report Number: 1000562954-2015-10127
• 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: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.434
• Device Lot Number: 9428279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR