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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA TI OFFSET LAMINA HOOK LOW PROFILE-RIGHT; PROSTHESIS, RIB REPLACEMENT
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SYNTHES USA TI OFFSET LAMINA HOOK LOW PROFILE-RIGHT; PROSTHESIS, RIB REPLACEMENT Back to Search Results
Catalog Number 497.262
Device Problem Fitting Problem (2183)
Patient Problem Failure of Implant (1924)
Event Date 12/16/2014
Event Type  malfunction  
Event Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon found postoperatively that there was a little difference in length of the implanted rod as compared to preoperative period.This report is 1 of 2 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.Without a lot number the device history record review and 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 OFFSET LAMINA HOOK LOW PROFILE-RIGHT
Type of Device
PROSTHESIS, RIB REPLACEMENT
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 Key4405166
MDR Text Key5128741
Report Number2520274-2015-10237
Device Sequence Number1
Product Code MDI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PH030009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number497.262
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2014
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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