MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREW,EMERG,AXS,ST,1.9X5MM,5P; IMPLANT

Catalog Number	56-19005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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.

• Brand Name: BONE SCREW,EMERG,AXS,ST,1.9X5MM,5P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8680725
• Report Number: 0008010177-2019-00030
• Device Sequence Number: 19398187
• Product Code: JEY
• UDI-Device Identifier: 37613327358446
• UDI-Public: 37613327358446
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K172572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 56-19005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention