MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN MONO/POLYAXIAL SCREWS

Catalog Number UNK MONO/POLYAXIAL SCREWS

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Spinal Column Injury (2081); Not Applicable (3189)

Event Date 02/01/2018

Event Type  Injury  

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

Dr.(b)(6) performed a t10-s1 procedure on the patient in (b)(6) 2017 with expedium 5.5 mm system with cobalt rods.At an unknown point in time the left s1 locking cap came loose from the screw head and the screw slipped off the rod.Dr.(b)(6)thought that in hind sight he should have give the patient anterior column support with an interbody fusion at l5-s1.On (b)(6) 2018 he performed the revision.For stage 1 he did an alif on the patient at l5-s1 using a ldr roi device.He then flipped the patient posterior and did the posterior revision.He cut the rods bilateral just caudal to l3 and took out the l5 and s1 expedium screws bilaterally(no screws were implanted in l4).He then placed larger diameter expedium screws in l5 and s1.He then placed iliac screws in the patient.He then placed inline rod to rod connectors from the expedium set on the existing rods caudal to l3.He then contoured new cobalt rods and placed these in the rod to rod connectors and then connected the rods to the screws at l5, s1, and ilium.He final tightened everything and successfully completed the procedure.Weight and height are unknown.I could not enter the unknown size expedium screw from left s1 in the part section.The system gave me error messages when i put in "unknown spn product".It gave me cannot put in parts for different operating companies.This is all the information available.No customer response needed.Patient consequence?: no.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

• Brand Name: UNKNOWN MONO/POLYAXIAL SCREWS
• Type of Device: UNKNOWN
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; CH
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7283370
• MDR Text Key: 100468465
• Report Number: 1526439-2018-50150
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK MONO/POLYAXIAL SCREWS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR