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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREW,EMERG,AXS,ST,1.9X5MM,5P; IMPLANT
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STRYKER LEIBINGER FREIBURG BONE SCREW,EMERG,AXS,ST,1.9X5MM,5P; IMPLANT Back to Search Results
Catalog Number 56-19005
Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2019
Event Type  Injury  
Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device not available for evaluation.
 
Event Description
It was reported that following bi-lateral mandible distraction surgery, the left distractor remained in place, but the right distractor plate came off the bone.The plate was intact, but the screws had loosened.A revision surgery will be done.
 
Event Description
It was reported that following bi-lateral mandible distraction surgery, the left distractor remained in place, but the right distractor plate came off the bone.The plate was intact, but the screws had loosened.A revision surgery will be done.
 
Manufacturer Narrative
A confirmation of the reported event that ¿right plate (62-02321) came off the bone¿ which is related to postoperative screw loosening was not applicable since the screws were not returned for investigation.Further questions were sent to the sales rep.And following important information were provided via email: ¿(¿) 3.What was patient age? 2 months 4.Can you provide a description of the patient¿s bone quality? very poor in the area of screw loosening.Soft and super thin.Where the bone was in much better condition (anterior segment-screw purchase was excellent) (¿) 14.Why was a self-tapping emergency screw used and when - during initial procedure or used within revision surgery? bc the original screw didn¿t have adequate purchase.It was used during the initial procedure (¿)¿ most likely the information provided indicate that the reason for the loosening of the screws under complaint is not related to a product problem but related to the very poor bone quality of the patient ¿ surgeon was forced to use emergency screw already during initial surgery to get the pmd fixed to the bone.Based on statistical evaluation there are no indications for any systematic design, material or manufacturing related issue.Therefore, no preventive and/or corrective actions are deemed necessary at this time.The complaint is added to the complaint trend.
 
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Brand Name
BONE SCREW,EMERG,AXS,ST,1.9X5MM,5P
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
MDR Report Key8680725
MDR Text Key147442137
Report Number0008010177-2019-00030
Device Sequence Number1
Product Code JEY
UDI-Device Identifier37613327358446
UDI-Public37613327358446
Combination Product (y/n)N
PMA/PMN Number
K172572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number56-19005
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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