MAUDE Adverse Event Report: 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 28MM; SCREW, FIXATION, BONE

Model Number	212.208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: ktt, hrs.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Complainant part is not expected to be returned for manufacturer review/investigation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
This report is against user facility medwatch number (b)(4), a copy is attached.The only information contained in this report is correction or additional information.This report captures one 5.0mm locking screw slf-tpng with t25 stardrive recess 28mm.This is report 6 of 10 for (b)(4).The other screw is being captured on related (b)(4).

• Brand Name: 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 28MM
• Common Device Name: SCREW, FIXATION, BONE
• MDR Report Key: 7497921
• Report Number: 2939274-2018-52089
• Device Sequence Number: 1124522
• Product Code: HWC
• UDI-Device Identifier: 10886982152152
• UDI-Public: (01)10886982152152
• Combination Product (Y/N): N
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 212.208
• Device Catalogue Number: 212.208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention