MAUDE Adverse Event Report: DEPUY SYNTHES SPINE UNKNOWN DEPUY VIPER SCREW

Catalog Number UNK ¿ SPINAL IMPLANT

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Paresis (1998); Hypoesthesia, Foot/Leg (2354)

Event Date 09/12/2015

Event Type  Injury  

Manufacturer Narrative

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

This complaint is related to synthes (b)(4).This complaint is about the removal of the 2 screws during a synthes complaint: on (b)(6) 2015: adding 4 screws in vertebrae.On (b)(6) 2015: removal of 2 screws of depuy (viper system) because they were touching the nerve.Removal of the pedicle screws on the right due to the apparition of a paresis and hypoesthesia in the right foot in the territory of l5 (no hematoma but suspicion of a radicular conflict with the pedicel screws).

• Brand Name: UNKNOWN DEPUY VIPER SCREW
• Type of Device: UNKNOWN DEPUY VIPER SCREW
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5268413
• MDR Text Key: 32745694
• Report Number: 1526439-2015-11046
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: UNK ¿ SPINAL IMPLANT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/06/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR