MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONESCREW,AXS,SD,2.0X4MM,5P; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number	56-20494
Medical Device Problem Codes	Device Slipped (1584); Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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 screw had come loose in the patient, necessitating a reoperation.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: d6a, d6b, h6 correction: d2a, d2b.The reported event could not be confirmed, as the device was not returned to freiburg for investigation and no images were available for review.Based on statistical evaluation, there are no indications for any systematic design, material or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.

• Brand Name: BONESCREW,AXS,SD,2.0X4MM,5P
• Common Device Name: SCREW, FIXATION, INTRAOSSEOUS
• 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 ; +49 7614888208
• MDR Report Key: 24428581
• Report Number: 0008010177-2026-00016
• Device Sequence Number: 10304307
• Product Code: DZL
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: 56-20494
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 06/22/2026
• 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