MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LC-DCP® PLATE 6 HOLES/77MM; PLATE, FIXATION, BONE

Model Number	223.56
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Original implant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used for: the reported event required medical/surgical intervention to preclude permanent damage to a body structure.Device history records review not available to report at this time.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a patient healed and contacted the hospital to have the hardware removed.On (b)(6) 2018, a 3.5mm lc-dcp plate and 6 cortical screws were removed successfully.Reason for removal of hardware was due to the patient presenting with a slight prominence of the implants.Revision surgery was completed successfully with no delay.No fragments were generated during the procedure.The patient is reported in stable condition.This report is for two (2) devices.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Patient height reported as 5¿2¿.Additional patient identifier: (b)(6), dhr review was completed.Part number: 223.56, lot number: 6243738, part manufacture date: 22-oct-2009 , manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm lc-dcp plate 6 holes/77mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Corrected data: initial reporter telephone and email.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.

• Brand Name: 3.5MM LC-DCP® PLATE 6 HOLES/77MM
• 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 Key: 7450611
• Report Number: 2939274-2018-51849
• Device Sequence Number: 18858475
• Product Code: HRS
• UDI-Device Identifier: 10886982157904
• UDI-Public: (01)10886982157904
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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 Number: 223.56
• Device Catalogue Number: 223.56
• Device Lot Number: 6243738
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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
• Patient Age: 25 YR
• Patient Weight: 53