MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T-PAL TI SPACER 10MM X 28MM 10MM HEIGHT - STERILE; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	04.812.010S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Expiration date and lot number unknown.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 as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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) 2019, the patient underwent a revision procedure to remove the tpal (transforaminal posterior atraumatic lumbar) titanium spacer due to the reported t-pal spacer that had migrated out of the l4-l5 disc space.Initially, the patient underwent an l3-l5 tlif posterior spinal fusion procedure on (b)(6) 2019.It is unknown if there was a surgical delay.The surgical outcome is unknown but with a patient consequence.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: T-PAL TI SPACER 10MM X 28MM 10MM HEIGHT - STERILE
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9517076
• Report Number: 2939274-2019-62774
• Device Sequence Number: 1699463
• Product Code: MAX
• UDI-Device Identifier: 10705034817156
• UDI-Public: (01)10705034817156
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 04.812.010S
• Device Catalogue Number: 04.812.010S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR