MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/14MM; SCREW, FIXATION, BONE

Model Number	206.014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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.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 or Problem Description
It was reported that on (b)(6) 2018, patient had symptoms of swelling, itching and a rash immediately following an unknown orthopedic procedure.The patient was implanted with a locking compression (lcp) one-third tubular plate with collar, a cancellous bone screw and a self-tapping locking screw due to a fracture.The patient is inquiring if the implants are coated with "polyethylene, polypropylene glycol, or wax", to which they are allergic.Patient has a history of a prior unknown surgery involving levels c4, c5, c6 and suffered an allergic reaction from an unknown metal object placed on the chest.The patient consulted the doctor on (b)(6) 2018 with a persistent ankle rash.X-rays were taken on an unknown date and confirmed that the fracture was healing well.It was confirmed by engineering on december 2, 2018 that the devices are 316l stainless steel and not coated with polyethylene, polypropylene glycol, or wax.This report is for a 4.0mm cancellous bone screw fully threaded/14mm.This is report 3 of 3 for (b)(4).

• Brand Name: 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8173442
• Report Number: 2939274-2018-55435
• Device Sequence Number: 16508579
• Product Code: HWC
• UDI-Device Identifier: 10886982147226
• UDI-Public: (01)10886982147226
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 206.014
• Device Catalogue Number: 206.014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR