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Model Number 11-1444-3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Damage to Ligament(s) (1952)
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Event Date 10/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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Upon completion of an audit of the dj orthopedics (b)(4), fda issued a finding on 13 december 2018 that "procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established." this report is being submitted as part of djo's efforts to address this finding.Device evaluated by mfr: no device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.The lot number was not provided, so no device history record review could be performed.Complaint data for similar products and issues going back 9 months has been reviewed.The trend indicates that reported customer complaints are within control.
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Event Description
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It was reported that the patient was playing football while wearing the brace.He went to make a cut around the defender and was tackled at the waist.He had to be helped off the field; he told the trainer he felt a pop.The doctor ordered a magnetic resonance image (mri) the following day.The patient found out the day after that he had re-torn his anterior cruciate ligament (acl) and damaged his meniscus.Further information was requested, but not provided.
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Search Alerts/Recalls
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