|
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.
|
|
Search Alerts/Recalls
|
|
|