MAUDE Adverse Event Report: DEPUY SPINE INC TITANIUM SCREWS; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 174168000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the titanium screw head was broken (detached) during the spine fusion surgery on (b)(6) 2018 when the surgeon inserted the 3rd screw into titanium ring (p/n: 1741-73-000) to fix titanium mesh (p/n: 1741-48-000).The broken screw could not be removed from titanium ring (p/n: 1741-73-000) so that the surgeon cut the titanium mesh (p/n: 1741-48-000) to maintain in 30mm dimension.Then, it was also reported that another screw head was broken (detached) when the surgeon implanted the above cut titanium mesh with 1st broken screw.The surgeon decided to implant the remained the titanium mesh into the patient¿s body with broken screw.There was less than 30min.Surgical delay.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).

• Brand Name: TITANIUM SCREWS
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8116447
• MDR Text Key: 129470675
• Report Number: 1526439-2018-51105
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 10705034018140
• UDI-Public: (01)10705034018140
• Combination Product (y/n): N
• PMA/PMN Number: K003043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

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
• Device Operator: Health Professional
• Device Model Number: 174168000
• Device Catalogue Number: 174168000
• Device Lot Number: CA5BY02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1