MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN MEDPOR TITAN SHEET - BTB - 38MM 50MM X 0.6MM; IMPLANT

Model Number	81024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing pain and insisted on having the implant removed.Surgeon performed the second surgery to remove the implant and noted there appeared to be no issues with the implant.
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 the patient was experiencing pain and insisted on having the implant removed.Surgeon performed the second surgery to remove the implant and noted there appeared to be no issues with the implant.
Additional Manufacturer Narrative
Corrected data: it has been confirmed by a medical expert that the stryker device did not cause and/or contribute to the event as described; therefore, the mdr record that was filed, is not valid.Please see communication attached in the communication log.

• Brand Name: MEDPOR TITAN SHEET - BTB - 38MM 50MM X 0.6MM
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16770292
• Report Number: 0008010177-2023-00021
• Device Sequence Number: 3251870
• Product Code: JEY
• UDI-Device Identifier: 07613252084259
• UDI-Public: 07613252084259
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K142568
• 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): 06/29/2023

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: 81024
• Device Catalogue Number: 81024
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/29/2023
• 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