MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DYNAMIC MESH STD FOR 1.5/1.7MM SCREWS, 200X200MMX0.6MM; IMPLANT

Model Number	54-00647
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
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.
Event or Problem Description
It was reported that mesh had been implanted for 16 years and recently, it was found that it was broken.There was a revision surgery performed to remove the mesh.
Event or Problem Description
It was reported that mesh had been implanted for 16 years and recently, it was found that it was broken.There was a revision surgery performed to remove the mesh.
Additional Manufacturer Narrative
The reported event could be confirmed, because of the picture provided.The device was not returned, therefore physical inspection could not be performed.This report is based on provided information only.In order to obtain more details about the reported event, the sales rep was and it was further reported that the device had been removed, but the patient and the hospital did not agree to return the device.Furthermore, the breakage has been determined, because there was abnormal noise in the head of the patient and during an examination in the hospital it was found that the mesh was broken.Bone healing was achieved.Additionally, a picture of the mesh under complaint was provided.It is not possible to determine the root cause of the breakages only with this picture.Based on the evaluation no indications for any material or manufacturing related problems were found in this investigation.Therefore, no corrective and/or preventive actions are deemed necessary at this time.If the device and / or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : discarded.

• Brand Name: DYNAMIC MESH STD FOR 1.5/1.7MM SCREWS, 200X200MMX0.6MM
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 15382240
• Report Number: 0008010177-2022-00032
• Device Sequence Number: 20288747
• Product Code: JEY
• UDI-Device Identifier: 04546540237668
• UDI-Public: 04546540237668
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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 Model Number: 54-00647
• Device Catalogue Number: 54-00647
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown