MAUDE Adverse Event Report: SYNTHES MEZZOVICO TI CRANIAL FLAP TUBE CLAMP 11MM DIA-STERILE; PLATE,CRANIOPLASTY,PREFORMED,NONALTERABLE

Catalog Number 460.100.01S

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Date of event was reported as (b)(6) 2017.However, it is unknown if the device malfunctioned on the date or if the malfunction was detected on the date.Udi# (b)(4).Date of implant is unknown.It was not reported if the explant procedure was planned or completed.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Reporter facility contact number (b)(6).Device history records review was completed for part# 460.010.01s, lot# l094299.Manufacturing location: (b)(4), manufacturing date: aug 12, 2016, expiry date: aug 01, 2026.No non conformance reports 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.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 europe reports an event in (b)(6) as follows: physician reported loosening of system and displacement of shallow bones.This report is for one (1) ti cranial flap tube clamp 11mm dia-sterile.This is report 7 of 10 for (b)(4).

• Brand Name: TI CRANIAL FLAP TUBE CLAMP 11MM DIA-STERILE
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6693189
• MDR Text Key: 79285455
• Report Number: 1000562954-2017-10124
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K992000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 460.100.01S
• Device Lot Number: L094299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1