DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35 N/A 01.03956.035

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-06-29 for DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35 N/A 01.03956.035 manufactured by Zimmer Gmbh.

Event Text Entries

[112706650] Concomitant medical products: - dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35, item# 01. 03956. 035, lot# 2906964; - dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x40, item# 01. 03956. 040, lot# 2856206; - dynesys lis, stabilizing cord, 200, item# 01. 03711. 200. Lot# 2865949 therapy date for all devices: (b)(6) 2018, the device history records were reviewed and found to be conforming. The manufacturer did not receive explanted devices for review. X-rays or other source documents were not provided for review. An e-mail requesting additional information was sent. A cause for this specific event cannot be ascertained from the information provided. As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. (b)(4). The following reports are associated with this event: a 0009613350-2018-00486 dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35, lot 2906964; 0009613350-2018-00662 dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35, lot 2820446; 0009613350-2018-00663 dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x40 lot 2856206; 0009613350-2018-00664 dynesys lis, stabilizing cord, 200, lot 2865949.
Patient Sequence No: 1, Text Type: N, H10


[112706651] It was reported that a child underwent a dynesys scoliosis tethering procedure at (b)(6) in usa. Upon returning to the (b)(6), the patient developed shortness of breath, haemothorax and lung collapse. Subsequently the implants were removed. It was further reported that the implants appeared infected. The screws were found to be cut and abutting the aorta. A screw head was occluding the right middle lobe. Note: both user reports from (b)(4) (mw5075989) have been received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0009613350-2018-00662
MDR Report Key7649721
Report SourceOTHER
Date Received2018-06-29
Date of Report2018-09-19
Date of Event2018-02-05
Date Mfgr Received2018-09-12
Device Manufacturer Date2015-09-23
Date Added to Maude2018-06-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER GMBH
Manufacturer StreetSULZER ALLEE 8 SULZER INDUSTRIE PARK
Manufacturer CityWINTERTHUR 8404
Manufacturer CountrySZ
Manufacturer Postal Code8404
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameDYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35
Generic NameDYNESYS TOP-LOADING SPINAL SYSTEM
Product CodeNQP
Date Received2018-06-29
Model NumberN/A
Catalog Number01.03956.035
Lot Number2820446
ID Number00889024481602
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER GMBH
Manufacturer AddressSULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-06-29

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