MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MIS STRAIGHT ROD 5.5X300MM; POSTERIOR STABILIZATION ROD

Model Number SY921TS

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation: on-going at manufacturing site, supplemental report will be submitted when additional information is available.

Event Description

It was reported that two s4 straight rods broke; one on each side of the construct, 4 months, 24 days after implantation.Additional information has not been provided at the date of this report; if additional information is received, a supplemental report will be submitted.Medwatch reports submitted for this patient include: 9610612-2018-00569.

Manufacturer Narrative

Both rods are broke in two pieces.We made a visual inspection of the fracture surfaces.At the surfaces 1 & 2 there are minor signs of a fatigue breakage.Caused by the secondary damages rubbing of the surfaces against another the area of the final forced fracture is not clearly visible.At the surfaces 3 & 4 area of the fatigue breakage is clearly visible.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this problem at hand.The root cause for the problem is most probably usage and patient behavior related.The relatively large area of the rest forced fracture at the fracture surfaces 3 &4 are a hint for the influence of heavily forces like a fall of the patient (also mentioned in the case description).But the fatigue fraction on all four surface are a clearly hint, that sooner or later the rods had broken without an outer incident like a fall or other extreme external load.The rod was placed over a long distance (two vertebrae) and maybe under a strong tension.A material defect or a manufacturing error can be excluded.There is no capa necessary.

• Brand Name: ENNOVATE MIS STRAIGHT ROD 5.5X300MM
• Type of Device: POSTERIOR STABILIZATION ROD
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8142088
• MDR Text Key: 129613934
• Report Number: 9610612-2018-00570
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY921TS
• Device Catalogue Number: SY921TS
• Device Lot Number: 52372598
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/07/2018
• Device Age: 11 MO
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention