MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREW, MP, CROSS-PIN, DIAM.2.0X6MM,; IMPLANT

Catalog Number	50-20706E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/15/2024
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.H3 other text : not available.
Event or Problem Description
It was reported a revision surgery was performed to revise the screws and plate due to the devices not meeting surgeons expectations.
Additional Manufacturer Narrative
Update: h6, d6a,b the devices involved in this case were not returned for direct evaluation.However, an image provided by the reporting party shows that two screws from the patient's left mandible plate had become loose.These two screws were the only ones confirmed to be loose.The case was reviewed by stryker's medical expert.His assessment concluded that the loose screws were likely attributable to the patient¿s poor bone quality in the maxilla.Specifically, regarding the two loose screws in the mandible, he suggested that they "could have been inserted over the tooth roots, at a position higher than recommended by the design proposal." in summary, the reported event appears to be related to the patient¿s compromised bone quality, combined with the possible misplacement of the screws over the tooth roots.Following a thorough investigation, no evidence was found to suggest any product malfunction, nor any design, material, or manufacturing defects.
Event or Problem Description
It was reported a revision surgery was performed to revise the screws and plate due to the devices not meeting surgeons expectations.

• Brand Name: BONE SCREW, MP, CROSS-PIN, DIAM.2.0X6MM,
• 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: 19288913
• Report Number: 0008010177-2024-00044
• Device Sequence Number: 15221287
• Product Code: JEY
• UDI-Device Identifier: 04546540603258
• UDI-Public: 04546540603258
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 50-20706E
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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: Male