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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW, FIXATION, BONE Back to Search Results
Device Problem Unintended Movement
Event Type  Injury  
Manufacturer Narrative

This report is for six (6) unknown screws/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.

 
Event Description

It was reported that a patient underwent a 3-level anterior cervical interbody fusion (acif) from the c4-c7 levels on (b)(6) 2017 using the synthes vectra plating system, two levels of 7mm lordotic cortico-cancellous anterior cervical fusion (cc acf) frozen allograft, and one level of 8mm lordotic cc-acf frozen allograft. After the interbody fusions were complete, a 3-level vectra plate (48mm) was implanted along with seven (7) 4. 0mm x 16 unknown screws and one (1) 4. 5mm x 16 unknown screw. Prior to closing, the surgeon verified that all implants were properly placed and all of the screws were properly locked into the plate. The surgery was completed successfully and no adverse events were reported against the patient. Postoperatively, on an unknown date, x-rays were taken and it was identified that the lowest two (2) of the implanted screws at c7 had backed out of the plate by approximately 3mm. On (b)(6) 2018, the patient was returned to the operating room. During the procedure, the vectra plate and all eight (8) screws were explanted. Several of the other screws were noted to be loose; however, they were still locked into the plate. After removing the implanted devices, the patient was implanted with a 3-level skyline plate with screws. The revision surgery was completed successfully and there was no injury noted to the patient¿s esophagus. Concomitant devices reported: titanium vectra plate 3 level/48mm (part 04. 613. 248, lot number unknown, quantity 1) 4. 0mm titanium cervical self-retaining screws (part 04. 613. 516, lot number unknown, quantity unknown), 4. 5mm titanium cervical self-retaining screws (part 04. 613. 566, lot number unknown, quantity unknown) this report is for six (6) unknown screws this is report 3 of 3 for (b)(4).

 
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Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7431171
Report Number2939274-2018-51711
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/13/2018 Patient Sequence Number: 1
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