MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN FLEXBLOCK TF2 - MEDIUM - LEFT - 74MM X 93MM X 20MM; IMPLANT

Catalog Number	9859
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient needed a revision surgery due to the wrong placing of the implant.The implant was removed, and a smaller implant was placed in the proper position.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Additional Manufacturer Narrative
Additional information: h6.The reported event could be confirmed.The stryker sales representative confirmed that the surgeon placed the implant upside down, causing uneven tissue coverage and increased projection, and possibly selected the wrong size, with no product defects reported.A second surgery was performed to replace the implant, and without a lot number, manufacturing and quality record reviews were not possible; thus, the root cause was determined to be surgical error.Based on the information provided, the device history and the inspection of the product, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.
Event or Problem Description
No new information.

• Brand Name: FLEXBLOCK TF2 - MEDIUM - LEFT - 74MM X 93MM X 20MM
• 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: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 21242137
• Report Number: 0008010177-2025-00013
• Device Sequence Number: 3688518
• Product Code: FWP
• UDI-Device Identifier: 07613252086413
• UDI-Public: 07613252086413
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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 Catalogue Number: 9859
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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