MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.5MM TI CANC LOCK SCRW 51MM THRD LGTH; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	489.171
Medical Device Problem Codes	Material Integrity Problem (2978); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 an unknown date, the surgeon performed an l2 lateral corpectomy with supplemental plate fixation from l1-l3 with depuy synthes tslp lateral plate on (b)(6) 2021.The surgeon got x-rays in ( b)(6) 2022 showing the expandable cage had subsided into the l1 vertebral body with one of the screws from the tlsp plate in l1 body broken at the neck of the screw close to the screw/plate interface.The patient was stable with no clinical issues.The patient had experienced a post-op device malfunction.This report is for one (1) 5.5mm ti canc lock scrw 51mm thrd lgth.This is report 2 of 5 for complaint (b)(4).
Event or Problem Description
The initial complaint was reviewed and found not reportable.There is no allegation against this device and the reported information does not reasonably suggest that the device may have caused or contributed to a serious injury.

• Brand Name: 5.5MM TI CANC LOCK SCRW 51MM THRD LGTH
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15080315
• Report Number: 2939274-2022-02835
• Device Sequence Number: 17418611
• Product Code: KWQ
• UDI-Device Identifier: 10705034784359
• UDI-Public: (01)10705034784359
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: PRE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 489.171
• Device Catalogue Number: 489.171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male