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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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MEDTRONIC SOFAMOR DANEK USA, INC ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 7480100
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 03/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device fragment in patient.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that intra-op, while the sounding feeler probe was being used in the vertebral body, the tip of the instrument broke and was left inside the vertebral body.X-ray was done to confirm the exact location of the broken tip of the instrument.The results of this x-ray are unknown currently.
 
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Brand Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key9953725
Report Number1030489-2020-00446
Device Sequence Number2817458
Product Code LXH
UDI-Device Identifier00721902760303
UDI-Public00721902760303
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/13/2020
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
Operator of Device Health Professional
Device Catalogue Number7480100
Device Lot NumberKH17J262
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/17/2020
Initial Report FDA Received Date04/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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