MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	889.836
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: part number: 889.836, lot number: 4587732, date of manufacture: 07/22/2003, place of manufacture: (b)(4), part expiration date: n/a.Description of dhr review: review of the device history records found a non-conformance report on part# 889.836 lot# 4587732.Visual nonconformity (black spot on surface) for one part.This part was reworked at the inspection operation.The part was re-inspected after rework and the conforming parts were moved on to the balance of the manufacturing operations.This non-conformance is not relevant to the complaint.Visual inspection: the vertebral spacer-tr 10mmx27mm 11mm height (p/n 889.836 l/n 4587732) was received at customer quality, and it was observed that the device was broken into 6 pieces.The complaint is confirmed.Device failure/ defect identified? yes.Dimensional inspection: an accurate dimensional inspection of the vertebral spacer was not able to be performed because of the post manufacturing deformation.Document/ specification review: the respective drawing(s) was reviewed: a manufacturing record evaluation found a non-conformance report on part# 889.836 lot# 4587732.Visual nonconformity (black spot on surface) for one part.This part was reworked at the inspection operation.The part was re-inspected after rework and the conforming parts were moved on to the balance of the manufacturing operations.This non-conformance is not relevant to the complaint.Complaint confirmed? yes.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 vertebral spacer was found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) vertebral spacer-tr 10mmx27mm 11mm height.This is report 1 of 1 for (b)(4).

• Brand Name: VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9182929
• Report Number: 2939274-2019-61478
• Device Sequence Number: 11410942
• Product Code: MQP
• UDI-Device Identifier: 10705034800295
• UDI-Public: (01)10705034800295
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K011037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 889.836
• Device Catalogue Number: 889.836
• Device Lot Number: 4587732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1