MAUDE Adverse Event Report: MSD BARTLETT MFG CAPSTONE PEEK VERT BODY SPACER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	2980001
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via manufacturer representative regarding a patient having tlif (transforaminal lumbar interbody fusion) (levels implanted l4-l5) due to degenerative disc l4-l5 level.It was reported that after capstone cage was inserted in rod inserter , surgeon inserted it in the l4-l5 level, after hammering , the screw at end got loose and dr tried to tighten it , but it didn't happen.But the cage was inserted inside the disc space at appropriate desired place.When rod inserter was removed , it had spiral threading of the capstone peek material attached to it.Inserter had smaller threading part than usual.It caused the screw to loosen up while hammering and when surgeon tried to tighten the screw again, there was a cross threading and peek material spiral threading was seen at the end of the inserter when removed.There were no patient symptoms reported.The product remains implanted.No further complications were reported.

• Brand Name: CAPSTONE PEEK VERT BODY SPACER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• MDR Report Key: 10625985
• Report Number: 1030489-2020-01369
• Device Sequence Number: 3248441
• Product Code: MAX
• UDI-Device Identifier: 00721902996689
• UDI-Public: 00721902996689
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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: 2980001
• Device Catalogue Number: 2980001
• Device Lot Number: MA05J133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR