MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MESH/1.7MM, DYNAMIC 90X90X.3MM; IMPLANT

Catalog Number	54-00346
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
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.H3 other text : implanted.
Event or Problem Description
It was reported there was a revision surgery performed to repair the bone graft as it did not have the expected outcome.The procedure was completed successfully.
Additional Manufacturer Narrative
It was determined after receiving further clarification from stryker's global medical expert and the log files from the device, this event was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify an mdr was not required for this event.H3 other text : implanted.
Event or Problem Description
It was reported there was a revision surgery performed to repair the bone graft as it did not have the expected outcome.The procedure was completed successfully.

• Brand Name: MESH/1.7MM, DYNAMIC 90X90X.3MM
• 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: 18691824
• Report Number: 0008010177-2024-00012
• Device Sequence Number: 7070567
• Product Code: JEY
• UDI-Device Identifier: 04546540237606
• UDI-Public: 04546540237606
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 54-00346
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/14/2024
• 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