MAUDE Adverse Event Report: DEPUY SYNTHES SPINE THREE-LEVEL PLATE, 51MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 183613051

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2015

Event Type  malfunction  

Event Description

Upon final tightening of the c5 screw, the threaded driver tip broke off into the head of the screw.Tightening was continued until the bushing popped out of the plate.The screw and bushing were removed and that plate hole was left empty.

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation with the results.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not available for investigation.

• Brand Name: THREE-LEVEL PLATE, 51MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 4685498
• MDR Text Key: 5689941
• Report Number: 1526439-2015-10280
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 183613051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EAGLE/SWIFT SCR, PRM, ST, 14MM (B)(4)
• Patient Age: 42 YR