DJO, LLC EXOS SHORT THUMB SPICA II (STSII), HAND BASED, BLK, L, L; ORTHOSIS, LIMB BRACE
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Model Number 212-61-1111 |
Device Problem
Crack (1135)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 10/01/2018 |
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.No lot number was provided, so a device record review could not 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 volleyball when he was injured while wearing the brace, requiring surgery to the thumb.The brace reportedly cracked during the incident.Further information was requested, but not provided.
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Search Alerts/Recalls
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