MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X50MM CANULATED; POSTERIOR STABILISATION

Model Number SY635TS

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paresis (1998)

Event Date 11/08/2018

Event Type  Injury  

Manufacturer Narrative

Exemption number: e2014018.Manufacturing site evaluation: product received along with 2 set screws.Investigation - with the exception of slight wear, caused by implantation and revision, there are no damages visible.The 2 enclosed set screws are in a proper condition.Batch history review - the manufacturing documents have been checked and found to be according to specifications valid during the time of production.There are no further complaints with this lot at hand.Conclusion and root cause - the root cause for the problem is most likely usage related.Rationale - according to the description, it refers to misplacement of a screw.The root cause would not be the product.According to the ifu, the surgeon is responsible for implantation of the screw and ensuring proper placement through intraoperative imaging.If this is not done, a misplacement can occur and lead to post-surgical complications.No further actions are required.

Event Description

It was reported that a patient underwent a revision due to misplacement of a spinal screw.The patient was in a non-interventional study in (b)(6).The original implant date was (b)(6) 2018 where an ennovate polyaxial screw and 2 set screws were placed in l3.Postoperatively, 1 day later, paresis kg 1-2/5 hip flexor left was noted, without pain.Misplacement of the l3 screw was determined by unspecified examination results.Revision surgery was performed on the same day, (b)(6) 2018, when the polyaxial screw and set screws were removed.Patient outcome stated permanent impairment, with paresis kg 3/5 hip flexor left.Further information about patient condition, diagnoses, additional concomitant devices, and laboratory or diagnostic results were not provided.

• Brand Name: ENNOVATE POLYAX.SCREW 6.5X50MM CANULATED
• Type of Device: POSTERIOR STABILISATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8139287
• MDR Text Key: 129572208
• Report Number: 9610612-2018-00533
• 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: company representative,foreig
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SY635TS
• Device Catalogue Number: SY635TS
• Device Lot Number: 52462366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Distributor Facility Aware Date: 11/16/2018
• Device Age: 1 MO
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 SET SCREWS: REF SY001TS, BATCH 52431059; 2 SET SCREWS: REF SY001TS, BATCH 52431059
• Patient Outcome(s): Required Intervention; Disability