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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS S4 CLOSED/OPEN DOMINO CONNECTOR 11MM MPLANTS POSTERIOR STABILISATISW843T

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AESCULAP IMPLANT SYSTEMS S4 CLOSED/OPEN DOMINO CONNECTOR 11MM MPLANTS POSTERIOR STABILISATISW843T Back to Search Results
Model Number SW843T
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2016
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing site evaluation:evaluation on-going.

 
Event Description

Country of complaint: (b)(6). On the primary surgery, fixation was done by using two connectors (sw843t) for both sides (left and right each). One month later, two connectors on the left were loosened. A year later, the connectors were completely uncoupled. On the(b)(6) 2016, rod on the other side was broken. No harm to the patient was reported.

 
Manufacturer Narrative

Investigation: used test and analysis equipment: -keyence vhx 600 d digital microscope. -panasonic dmc tz8 digital camera. We made a visual inspection of both connectors and the enclosed screws. One of the screws shows an incorrect wear pattern, caused by a slipping rod. The other screw shows a right but underdeveloped wear pattern, caused by an improper tightening. Both connectors exhibit strong wear, caused by an improperly applied or tightened rod. Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production. Conclusion and root cause: the root cause is most probably usage related. Rational: both connectors exhibit the typical signs of incorrectly applied rods and incorrectly tightened screws. No capa is necessary.

 
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Brand NameS4 CLOSED/OPEN DOMINO CONNECTOR 11MM
Type of DeviceMPLANTS POSTERIOR STABILISATISW843T
Manufacturer (Section D)
AESCULAP IMPLANT SYSTEMS
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 Key6216580
MDR Text Key63867576
Report Number9610612-2016-00009
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK123352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSW843T
Device Catalogue NumberSW843T
Device LOT Number52104365
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/21/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/13/2016
Device Age1 yr
Event Location No Information
Date Manufacturer Received12/06/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/16/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/30/2016 Patient Sequence Number: 1
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