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

Model Number 54-00646

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 10/10/2016

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 294150090
• Report Number: 0008010177-2022-00017
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 04546540237651
• UDI-Public: 04546540237651
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 54-00646
• Device Catalogue Number: 54-00646
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention