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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / LEFT; PLATE, FIXATION, BONE
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STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / LEFT; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 628207
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 04/12/2019
Event Type  Injury  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device disposition unknown.
 
Event Description
Clavicle revision case; revision was due to previous plate and screws pulling out from bone.Surgeon believes this was due to the patient 'lifting weights' in the gym earlier than advised after surgery.Revision case went according to plan with no issues encountered.
 
Manufacturer Narrative
Correction: h6 (conclusion).Additional information added to section b5.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence provided despite multiple attempts.Based on the given information, the root cause was attributed to be patient related.The failure was caused as the patient was not compliant.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
Clavicle revision case; revision was due to previous plate and screws pulling out from bone.Surgeon believes this was due to the patient 'lifting weights' in the gym earlier than advised after surgery.Revision case went according to plan with no issues encountered.Patient was compliant and in a sling for 2 months.Patient is also a heavy smoker and went back to work as a concreter after 2 months post case.
 
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Brand Name
SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / LEFT
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8839396
MDR Text Key152612678
Report Number0008031020-2019-00945
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613252442325
UDI-Public07613252442325
Combination Product (y/n)N
PMA/PMN Number
K113760
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number628207
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age22 YR
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