MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE); IMPLANT

Catalog Number	50-20512
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
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 it was found that the screws were loose.The surgeon performed a revision surgery and elected to remove a portion of the plate and screws by cutting it with a fissure burr.Surgery was completed successfully.
Additional Manufacturer Narrative
The reported event could not be confirmed, as the devices were not returned to freiburg for investigation.And no images were available for review.Review of the available information concluded as follows: as bone healing had already been achieved when the removal surgery was performed, the screws were sufficiently fixated to ensure that stability is achieved until bony healing has occurred.Therefore, the screws worked as intended.
Event or Problem Description
It was reported that it was found that the screws were loose.The surgeon performed a revision surgery and elected to remove a portion of the plate and screws by cutting it with a fissure burr.Surgery was completed successfully.

• Brand Name: LOCKING SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE)
• 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: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 17740758
• Report Number: 0008010177-2023-00059
• Device Sequence Number: 17601898
• Product Code: JEY
• UDI-Device Identifier: 37613154184447
• UDI-Public: 37613154184447
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K022185
• 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): 12/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 50-20512
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 12/27/2023
• 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