MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ZERO-P VA IMPLANT 8MM HEIGHT LORDOTIC-STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number	04.647.128S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event occurred on an unknown date in 2021.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.Investigation summary: customer quality investigation: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and the complaint condition was confirmed, as the image showed a broken spacer.As the implant(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.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 history review: a manufacturing record evaluation could not be performed as the lot number could not be determined from the image.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date in 2021, the zero-p va implant broke during an unknown procedure.There was no patient consequence.There is no further information available.This report is for one (1) zero-p va implant 8mm height lordotic-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: ZERO-P VA IMPLANT 8MM HEIGHT LORDOTIC-STERILE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11747843
• Report Number: 2939274-2021-02148
• Device Sequence Number: 19859114
• Product Code: OVE
• UDI-Device Identifier: 10705034750743
• UDI-Public: 10705034750743
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: 04.647.128S
• Device Catalogue Number: 04.647.128S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/29/2021
• Patient Sequence Number: 1