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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) TI CRANIAL FLAP TUBE CLAMP 13MM DIA; PLATE,CRANIOPLASTY,PREFORMED NONALTERABLE
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SYNTHES (USA) TI CRANIAL FLAP TUBE CLAMP 13MM DIA; PLATE,CRANIOPLASTY,PREFORMED NONALTERABLE Back to Search Results
Catalog Number 460.001
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2014
Event Type  malfunction  
Event Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the implant broke during implantation into the patient.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Without a 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
TI CRANIAL FLAP TUBE CLAMP 13MM DIA
Type of Device
PLATE,CRANIOPLASTY,PREFORMED NONALTERABLE
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key3897380
MDR Text Key15812667
Report Number2520274-2014-12180
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
PK992000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 05/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number460.001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/31/2014
Initial Date FDA Received06/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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