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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown rod/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that an order of patient-critical parts was delayed by twenty-four (24) hours due to missing paperwork.Concomitant devices: cancellousscr synapse ø3.5 (part: 04.614.016, lot: unknown, quantity: 2); cancellousscr synapse ø3.5 (part: 04.614.018, lot: unknown, quantity: 3); cancellousscr synapse ø3.5 (part: 04.614.024, lot: unknown, quantity: 4); cancellousscr synapse ø3.5 (part: 04.614.026, lot: unknown, quantity: 3); cancellousscr synapse ø3.5 (part: 04.614.028, lot: unknown, quantity: 8); cancellousscr synapse ø3.5 (part: 04.614.030, lot: unknown, quantity: 1); cancellousscr synapse ø3.5 (part: 04.614.032, lot: unknown, quantity: 4); shaft-scr synapse ø3.5 l26 tan (part: 04.614.326, lot: unknown, quantity: 2); shaft-scr synapse ø3.5 l28 tan (part: 04.614.328, lot: unknown, quantity: 2); shaft-scr synapse ø3.5 l30 tan (part: 04.614.330, lot: unknown, quantity: 8); shaft-scr synapse ø3.5 l32 tan (part: 04.614.332, lot: unknown, quantity: 10); shaft-scr synapse ø3.5 l34 tan (part: 04.614.334, lot: unknown, quantity: 2); cancellousscr synapse ø4.5 (part: 04.614.224, lot: unknown, quantity: 4); cancellousscr synapse ø4.5 (part: 04.614.226, lot: unknown, quantity: 4); cancellousscr synapse ø4.5 (part: 04.614.228, lot: unknown, quantity: 2); cancellousscr synapse ø4.5 (part: 04.614.230, lot: unknown, quantity: 4); cancellousscr synapse ø4.5 (part: 04.614.236, lot: unknown, quantity: 4); lockscr synapse tan (part: 04.614.508, lot: unknown, quantity: 20); rod ø3.5 l240 ti gold (part: 498.957, lot: unknown, quantity: 3); mono/polyaxial screw (part: unknown, lot: unknown, quantity: 1); locking/set screw (part: unknown, lot: unknown, quantity: 1).This report is for an unknown mono/polyaxial screws.This is report 2 of 3 for (b)(4).
 
Event Description
This report is for an unknown rod.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
UNK - RODS
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9749906
MDR Text Key192705822
Report Number8030965-2020-01363
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/03/2020
Patient Sequence Number1
Treatment
CANCELLOUSSCR SYNAPSE Ø3.5 L16 TAN; CANCELLOUSSCR SYNAPSE Ø3.5 L18 TAN; CANCELLOUSSCR SYNAPSE Ø3.5 L18 TAN; CANCELLOUSSCR SYNAPSE Ø3.5 L24 TAN; CANCELLOUSSCR SYNAPSE Ø3.5 L24 TAN; CANCELLOUSSCR SYNAPSE Ø3.5 L26 TAN; CANCELLOUSSCR SYNAPSE Ø3.5 L26 TAN; CANCELLOUSSCR SYNAPSE Ø3.5 L28 TAN; CANCELLOUSSCR SYNAPSE Ø3.5 L30 TAN; CANCELLOUSSCR SYNAPSE Ø3.5 L32 TAN; CANCELLOUSSCR SYNAPSE Ø4.5 L24 TAN; CANCELLOUSSCR SYNAPSE Ø4.5 L26 TAN; CANCELLOUSSCR SYNAPSE Ø4.5 L28 TAN; CANCELLOUSSCR SYNAPSE Ø4.5 L30 TAN; CANCELLOUSSCR SYNAPSE Ø4.5 L36 TAN; LOCKSCR SYNAPSE TAN; ROD Ø3.5 L240 TI GOLD; SHAFT-SCR SYNAPSE Ø3.5 L26 TAN; SHAFT-SCR SYNAPSE Ø3.5 L26 TAN; SHAFT-SCR SYNAPSE Ø3.5 L28 TAN; SHAFT-SCR SYNAPSE Ø3.5 L28 TAN; SHAFT-SCR SYNAPSE Ø3.5 L30 TAN; SHAFT-SCR SYNAPSE Ø3.5 L32 TAN; SHAFT-SCR SYNAPSE Ø3.5 L32 TAN; SHAFT-SCR SYNAPSE Ø3.5 L34 TAN; UNK - LOCKING/SET SCREWS: SYNAPSE; UNK - MONO/POLYAXIAL SCREWS: SYNAPSE
Patient Outcome(s) Required Intervention;
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