MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MIS SINGLE INNER SETSCW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 186715000

Device Problem Torn Material (3024)

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

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

Additional 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 made a supply of a fracture with ankylosing spondylitis with viper on level th10-l2.The sleeve at l1/left has loosen from the screw in the use of the torque limiter while the first attempt to lock.An attempt was made to replace the sleeve unfortunately failed.After presentation of the screw and the rod was an attempt to introduce the single innie with the approximater of the expedium.The thread squeaked and had not locked into place.At the second attempt free hand just over the sleeve then without approximater, also there tightening the innie in the head not succeeded, although they saw that was one "inside." the thread was broken when both innies.Since all other caps per torque were already locked, the surgeon has decided to close this a screw not an innie because everyone else already stable locked.Because the material explanting will take place in six months, he has every confidence that holds this construct! the surgeon takes to the threads of the bolt in l1 is left broken.Unfortunately, both defective single innies were discarded.(b)(4).

• Brand Name: MIS SINGLE INNER SETSCW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; raynham 02767 ; SZ 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 5970310
• MDR Text Key: 55449703
• Report Number: 1526439-2016-10699
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2016

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: Physician
• Device Catalogue Number: 186715000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/22/2016
• 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