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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MIS CURVED ROD 5.5X90MM IMPLANTS POSTERIOR STABILISATION

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AESCULAP AG ENNOVATE MIS CURVED ROD 5.5X90MM IMPLANTS POSTERIOR STABILISATION Back to Search Results
Model Number SY939TS
Device Problem Installation-Related Problem (2965)
Patient Problem No Code Available (3191)
Event Date 10/15/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: no product was returned. 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 error pattern at hand. Conclusion and root cause: the root cause for the problem is most probably usage related. Rationale: without further knowledge about the circumstances we assume that the screw was not placed correctly. The complained rod is defiantly not the root cause for the problem described in the complaint. No capa necessary.

 
Event Description

It was reported by the healthcare professional to the company sales representative "bone fragments have been pressed into the spinal canal by inserting the longitudinal beam into the screw that was screwed in too far. Implantation (b)(6) 2018. " a patient (b)(6) underwent spinal surgery on (b)(6) 2018 during a non-interventional clinical study (b)(6) and had a pedicle screw inserted too far into lw3 right side; a longitudinal rod was inserted into the screw and added additional pressure to the bone. B/one fragments were created and were found to have inadvertently pressed into the spinal canal. Evidence of the bone fragments was discovered and the patient underwent a revision on (b)(6) 2018. During surgery, reversal of the lw3 screw was performed. It was unknown if the longitudinal rod remained implanted. The bone fragments were retrieved and suturing of a very small dural tear was performed (caused by the bone fragments). Further surgical intervention was performed on (b)(6) 2018. The wound was examined and seroma was "relieved"; it was confirmed that there was no pus or spinal fluid leakage. This case addresses the third surgery. All medwatch submissions related to this report are: 9610612-2018-00504, 9610612-2018-00505 (this report). Concomitant products associated with this case include: 1- 6. 5 x 50 mm screw; 5 - 5 x 50 mm screws; 6 - set screws; 1 - 5. 5 x 80 rod; 1 - 30 x 11. 5 x 7mm t space peek; 1 - 34 x 11. 5 x 10mm t space peek.

 
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Brand NameENNOVATE MIS CURVED ROD 5.5X90MM
Type of DeviceIMPLANTS POSTERIOR 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 Key8055829
MDR Text Key126886217
Report Number9610612-2018-00505
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK180433
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 11/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSY939TS
Device Catalogue NumberSY939TS
Device LOT Number52415157
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/30/2018
Device Age5 mo
Event Location No Information
Date Manufacturer Received10/15/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/07/2018
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: 11/09/2018 Patient Sequence Number: 1
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