BREMER ADJUSTIBLE RING HT002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-11-12 for BREMER ADJUSTIBLE RING HT002 manufactured by Bremer Medical, Inc.

Event Text Entries

[20760913] The ring from the halo was put on the pt in order to put the pt in traction prior to putting on the halo vest. The orthotist had difficulty when he attempted to put on the traction bales because the bolts would not gain a purchase on the ring. He used a couple of longer bolts that he had in his possession. The traction bale and ring functioned well for five days, after which time the traction bale was removed and the pt put in an airflo vest. One half day later the pt noted that he could move his head. When the orthotist tried to tighten the bolts, they stripped the threads in the ring. When he tried to tighten the other four bolts that hold the ring together, they also stripepd. The halo vest was removed and the pt was put into another system.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1035798-1998-00001
MDR Report Key196948
Report Source05,06
Date Received1998-11-12
Date of Report1998-08-27
Date of Event1998-08-26
Date Mfgr Received1998-10-12
Date Added to Maude1998-11-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBREMER ADJUSTIBLE RING
Generic NameORTHOTIC BRACE
Product CodeHAX
Date Received1998-11-12
Returned To Mfg1998-08-31
Model NumberNA
Catalog NumberHT002
Lot Number28761
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagY
Date RemovedU
Device Sequence No1
Device Event Key191351
ManufacturerBREMER MEDICAL, INC
Manufacturer Address4801 DAWIN RD JACKSONVILLE FL 322079512 US
Baseline Brand NameBREMER ADJUSTABLE RING
Baseline Generic NameSKULL TONGS
Baseline Model NoNA
Baseline Catalog NoHT002
Baseline IDNA
Baseline Device FamilyBREMER HALO SYSTEM
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK915800
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1998-11-12

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