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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE); IMPLANT
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STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE); IMPLANT Back to Search Results
Catalog Number 50-20414
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 12/31/2013
Event Type  malfunction  
Event Description
It was reported that doctor was performing a mandible fracture parasymphasis on (b)(6)2013.He placed a screw into a plate with a pilot drill and when he was tightening the screw, the screw head broke off.
 
Manufacturer Narrative
Device not returned for evaluation as it could not be retrieved from the patient.If additional information is received it will be reported on a supplemental report.Surgeon could not retrieve it.
 
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Brand Name
BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE)
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-79 111
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-79 111
Manufacturer Contact
jamshed badarpura
boetzingerstr. 41
freiburg D-791-11
76145120
MDR Report Key3588151
MDR Text Key19021616
Report Number0008010177-2014-00012
Device Sequence Number1
Product Code JEY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/31/2013
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 Number50-20414
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/31/2013
Initial Date FDA Received01/22/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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