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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE OPEN LAT.OFFSET CONNECTOR 35MM; SPINE SURGERY

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AESCULAP AG ENNOVATE OPEN LAT.OFFSET CONNECTOR 35MM; SPINE SURGERY Back to Search Results
Model Number SY717TS
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 01/15/2024
Event Type  Injury  
Manufacturer Narrative
Investigation results: visual inspection: in the first step a visual inspection of all received components was made.The involved rods (sy439ts; sy440ts) were bent to the required shape during the operation but were not shortened or cut.Since all three (3) sy717ts have the same lot number, they are referred to with "a, b, c".The overall length of the individual sy171ts (a-c) was shortened from the original size of 52.11 mm to the following dimensions: sy717ts a = 31,97mm ; sy717ts b = 33,68 mm ; sy717ts c = 46,36 mm.In the next step, the width of the implant head was checked, and all measured values were within the specifications.Next, microscopic inspection of each component was made, especially the contact surfaces.Sy717ts-a shows a little wear at the lower edge of the body, the imprint on the flank runs over two thirds of the length and lies below the edge of the rod holder body, the off-center depression on the locking screw is a sign that the rod was not positioned too high in the rod holder body.Sy717ts-b shows little wear at both edges of the body, the anodized layer on the bottom of the body also has small, bare spots, which is a sign that the rod rested evenly on the bottom of the body, the imprint on the flank runs more than two thirds of the length in the middle and lies below the edge of the rod holder body, the off-center depression on the locking screw is a sign that the rod was not positioned too high in the rod holder body.Sy717ts-c shows practically no wear at the lower edge of the body, the imprint on the flank runs over the whole length but it lies directly on the edge of the rod holder body.The center depression on the locking screw in conjunction with the positions of the other impressions, this is a sign that the rod was not 100% correctly placed in the connector.Sy716ts shows clearly visible wear at both edges of the body, the imprint on the flank runs the entire length and lies below the edge of the rod holder body and shows clear signs of abrasion.The off-center depression on the locking screw is a sign that the rod was not positioned too high in the rod holder body, but it shows clearly signs of abrasion, too.On both rods (sy439ts; sy440ts, involved components) there are also traces of abrasion in one place.Batch history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot numbers.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision.Conclusion/preventive measures: the root cause for the problem could not be finally concluded.The pressure and chafing marks and the location of these features in some areas of the implants indicate that the positioning of the rods in relation to the connectors was not optimal in 100%.Since the implants themselves do not have any manufacturing-related defects and the documentation accompanying the production of the rods and connectors does not show any deviations, we can rule out a product-related cause for the complaint.Based upon the investigation results, a capa is not necessary.
 
Event Description
It was reported that there was an issue with the product sy717ts - ennovate open lat.Offset connector 35mm.According to the complaint description, there was postoperative loosening noted after four (4) years.A revision was performed on 15jan2024; dorsal revision and lengthening spondylodeses l2-ilium with replacement of connectors and strengthening of double-technique, and also side-to-side connection, and debridement.No further data was provided nor available.The adverse event is filed under aesculap ag reference no.(b)(4).Associated medwatch reports: 9610612-2024-00025 (aesculap ag reference no.(b)(4) - sy716ts).9610612-2024-00022 (aesculap ag reference no.(b)(4) - sy717ts).Involved components: aesculap ag reference no.(b)(4) - sy439ts/ ennovate curved rod 5.5x90mm.- lot 52729574.Aesculap ag reference no.(b)(4) - sy440ts/ ennovate curved rod 5.5x100mm - lot 52746257.
 
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Brand Name
ENNOVATE OPEN LAT.OFFSET CONNECTOR 35MM
Type of Device
SPINE SURGERY
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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key18791364
MDR Text Key336395964
Report Number9610612-2024-00022
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/26/2024
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? Yes
Device Operator Health Professional
Device Model NumberSY717TS
Device Catalogue NumberSY717TS
Device Lot Number52371669
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/31/2024
Initial Date FDA Received02/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SY439TS - LOT 52729574; SY440TS - LOT 52746257
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient SexMale
Patient Weight140 KG
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