MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SST EZ SPHERE - 16MM; IMPLANT

Catalog Number	80008
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
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.
Event or Problem Description
It was reported that the surgeon inserted one medpor implant, but no sutures could be properly placed.
Event or Problem Description
It was reported that the surgeon inserted one medpor implant, but no sutures could be properly placed.
Additional Manufacturer Narrative
The reported event could not be confirmed since the product was not returned for investigation.It was reported that the customer experienced a one-hour surgical delay but was able to successfully implant the device without requiring a second surgery.An expanded investigation (nc#(b)(4)) was initiated in (b)(6) 2019 to assess an adverse trend in suturing performance of medpor sphere implants; while no link to date of manufacture was found, all samples were suturable, and factors such as surgical technique, training, and suture needle type were acknowledged as key influences, with additional guidance provided in the product instructions.Based on the investigation, 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.

• Brand Name: SST EZ SPHERE - 16MM
• 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: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 21823350
• Report Number: 0008010177-2025-00038
• Device Sequence Number: 4289018
• Product Code: FWP
• UDI-Device Identifier: 07613252088561
• UDI-Public: 07613252088561
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/03/2025

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?: Yes
• Device Catalogue Number: 80008
• Device Lot Number: NN3PWR
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2023
• 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: Other; Required Intervention
• Patient Sex: Unknown