MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI SNAP-ON TRANSCONNECTOR 38MM-47MM FOR 5.5MM/6.0MM RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.633.338
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro codes: mnh, mni, kwq, kwp.This report is for one (1) ti snap-on transconnector 38 mm-47 mm for 5.5 mm/6.0 mm rods.Lot numbers is unknown; complainant part is expected to be returned for manufacturer review / investigation but has yet to be received.Initial reporter is company representative.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 the patient initially underwent a laminectomy of t11-l3 due to a fracture at l1, on (b)(6) 2019.Patient had a broken back requiring the surgery.Patient is now showing symptoms of hypersensitivity to the metal installed in patient¿s back during the fusion and currently experiencing increased pain and skin breakouts.An mri that was done in (b)(6) 2019 shows that the patient is healing as expected.There is no plan to remove the implants currently.This complaint involves one (1) device.This report is for one (1) ti snap-on transconnector 38 mm-47 mm for 5.5 mm/6.0 mm rods.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Event year reported as 2019; however exact date of postoperative allergic reaction development is unknown.Initial reporter occupation : reporter is patient.Mfr site : physical manufacturer.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: TI SNAP-ON TRANSCONNECTOR 38MM-47MM FOR 5.5MM/6.0MM RODS
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9123447
• Report Number: 2939274-2019-60899
• Device Sequence Number: 14034171
• Product Code: NKB
• UDI-Device Identifier: 10705034746661
• UDI-Public: (01)10705034746661
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.633.338
• Device Catalogue Number: 04.633.338
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR