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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM PELVIC CORTEX SCREW SELF-TAPPING 70MM; PLATE,FIXATION,BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM PELVIC CORTEX SCREW SELF-TAPPING 70MM; PLATE,FIXATION,BONE Back to Search Results
Model Number 204.670
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 12/17/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patent identifier: (b)(6).Additional product code hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not a.
 
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent for a surgery to remove hardware due to pain.The patient had some painful hardware after bone healing and thus requested it be removed if healing was completed.The healing was completed, so no longer needed hardware was removed.The original implantation date was unknown.The procedure outcome was unknown.There was no patient consequence.This complaint involves nine (9) devices.This report is for (1) 3.5mm pelvic cortex screw self-tapping 70mm.This report is 9 of 9 for (b)(4).
 
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Brand Name
3.5MM PELVIC CORTEX SCREW SELF-TAPPING 70MM
Common Device Name
PLATE,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key11156050
Report Number2939274-2021-00218
Device Sequence Number17138785
Product Code HRS
UDI-Device Identifier10886982146069
UDI-Public(01)10886982146069
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K131186
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/17/2020
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? No
Operator of Device Health Professional
Device Model Number204.670
Device Catalogue Number204.67
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/17/2020
Initial Report FDA Received Date01/12/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
3.5MM CORTEX SCREW SELF-TAPPING 44MM; 3.5MM PELVIC CORTEX SCREW SELF-TAPPING 65MM; 3.5MM PELVIC CORTEX SCREW SELF-TAPPING 65MM; 3.5MM PELVIC CORTEX SCREW SELF-TAPPING 70MM; 3.5MM PELVIC CORTEX SCREW SELF-TAPPING 75MM; 3.5MM PROXIMAL TIBIA PLATE 4 HOLES/RIGHT; 4.5MM CANNULATED SCREW PARTIALLY THREADED/46MM; 4.5MM CANNULATED SCREW PARTIALLY THREADED/48MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age22 YR
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