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U.S. Department of Health and Human Services

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

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AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X50MM CANULATED POSTERIOR STABILISATION Back to Search Results
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
(b)(4). 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.
 
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Brand NameENNOVATE POLYAX.SCREW 6.5X50MM CANULATED
Type of DevicePOSTERIOR STABILISATION
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8139287
MDR Text Key129572208
Report Number9610612-2018-00533
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K180433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSY635TS
Device Catalogue NumberSY635TS
Device Lot Number52462366
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/16/2018
Device Age1 MO
Event Location No Information
Date Manufacturer Received11/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/06/2018 Patient Sequence Number: 1
Treatment
2 SET SCREWS: REF SY001TS, BATCH 52431059
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