MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DYNAMIC MESH STD FOR 1.5/1.7MM SCREWS, 90X90MMX0.6MM; IMPLANT

Model Number	54-00646
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/10/2016
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.In addition to the mesh (54-00646), there were also quantity of 5 reported screws (50-15994) (which are captured in complaint # (b)(4).Device implanted.
Event or Problem Description
It was reported by the consumer that the surgeon performed a split duraplasty and over time, they are experiencing pain.They were advised that a second surgery will need to be performed.No additional information is known at this time.

• Brand Name: DYNAMIC MESH STD FOR 1.5/1.7MM SCREWS, 90X90MMX0.6MM
• 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 ; 76145120
• MDR Report Key: 14644016
• Report Number: 0008010177-2022-00017
• Device Sequence Number: 20212323
• Product Code: JEY
• UDI-Device Identifier: 04546540237651
• UDI-Public: 04546540237651
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K983528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 54-00646
• Device Catalogue Number: 54-00646
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/09/2022
• 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